Product Code: JJY FDA class 1 21 CFR 862.1660

Multi-Analyte Controls, All Kinds (Assayed)

Clinical Chemistry

This device consists of multi-analyte assayed controls used in clinical chemistry laboratories to simultaneously monitor the performance of analytical systems across multiple measurands in a single control run, enabling comprehensive quality assurance of laboratory test panels. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is JJY, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

View on FDA

510(k)s

673

FEI Numbers

127

Registration Numbers

127

Unique Applicants

167

Years Active

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Basic Information

Product Code: JJY
Device Class: FDA class 1
Regulation Number: 862.1660
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 673 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162530	Multichem IA Plus	Mar 31, 2017	Substantially Equivalent	Techno-Path Manufacturing
K163629	Audit MicroControls Linearity FD Tumor Markers II	Mar 10, 2017	Substantially Equivalent	Aalto Scientific, Ltd.
K163015	Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak	Jan 10, 2017	Substantially Equivalent	Bio-Rad Laboratories
K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit	Jan 28, 2016	Substantially Equivalent	Radiometer America, Inc.
K150300	Liquichek Cardiac Markers Plus Control LT	Dec 11, 2015	Substantially Equivalent	Bio-Rad Laboratories
K142964	VALIDATE Anemia Calibration Verification/ Linearity Test Kit	Apr 30, 2015	Substantially Equivalent	Maine Standards Company, LLC
K143379	Liquichek Maternal Serum II Control	Mar 13, 2015	Substantially Equivalent	Bio-Rad Laboratories
K143573	Audit MicroControls Linearity FD Tumor Markers II	Jan 16, 2015	Substantially Equivalent	Aalto Scientific, Ltd.
K140971	LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.	Dec 08, 2014	Substantially Equivalent	Randox Laboratories Limited
K142978	Audit MicroControls Linearity LQ Special Diabetes	Nov 20, 2014	Substantially Equivalent	Aalto Scientific, Ltd.
K133676	ABX PENTRA MICRO ALB CONTROL L/H	Jul 11, 2014	Substantially Equivalent	HORIBA ABX SAS
K141073	LIQUICHEK TUMOR MARKER CONTROL	Jun 23, 2014	Substantially Equivalent	Bio-Rad Laboratories
K140522	RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL	May 22, 2014	Substantially Equivalent	Randox Laboratories Limited
K140916	LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK	May 06, 2014	Substantially Equivalent	Bio-Rad Laboratories
K140764	LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK	Apr 25, 2014	Substantially Equivalent	Bio-Rad Laboratories
K134013	LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO	Apr 24, 2014	Substantially Equivalent	Bio-Rad Laboratories
K140393	RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3	Mar 25, 2014	Substantially Equivalent	Randox Laboratories Limited
K133960	LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL	Jan 22, 2014	Substantially Equivalent	Bio-Rad Laboratories
K132227	LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY	Oct 25, 2013	Substantially Equivalent	Bio-Rad Laboratories
K132156	RANDOX CSF CONTROLS LEVELS 2 AND 3	Oct 23, 2013	Substantially Equivalent	Randox Laboratories, Ltd.
K132751	MULTICHEM S PLUS / S PLUS (ASSAYED)	Oct 22, 2013	Substantially Equivalent	Techno-Path Manufacturing , Ltd.
K131993	MULTICHEM U	Oct 15, 2013	Substantially Equivalent	Techno-Path Manufacturing , Ltd.
K131479	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	Oct 07, 2013	Substantially Equivalent	Helena Laboratories
K131992	MULTICHEM P	Sep 25, 2013	Substantially Equivalent	Techno-Path Manufacturing , Ltd.
K132091	MULTICHEM IA AND IA PLUS	Sep 20, 2013	Substantially Equivalent	Techno-Path Manufacturing , Ltd.
K131595	EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM	Jul 26, 2013	Substantially Equivalent	Eurotrol B.V.
K130337	RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3	Jun 19, 2013	Substantially Equivalent	Randox Laboratories Limited
K130963	LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK	May 06, 2013	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K130762	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET	Apr 29, 2013	Substantially Equivalent	Aalto Scientific, Ltd.
K124009	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C	Apr 17, 2013	Substantially Equivalent	Diamond Diagnostics, Inc.
K130761	LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK	Apr 12, 2013	Substantially Equivalent	Bio-Rad Laboratories
K123725	FASTPACK CONTROL KIT	Mar 08, 2013	Substantially Equivalent	Qualigen, Inc.
K130162	LIQUID ASSAYED MULTIQUAL PREMIUM	Mar 01, 2013	Substantially Equivalent	Bio-Rad Laboratories
K123775	LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK	Jan 31, 2013	Substantially Equivalent	Bio-Rad Laboratories
K123663	LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK	Dec 27, 2012	Substantially Equivalent	Bio-Rad Laboratories
K123198	LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA	Nov 20, 2012	Substantially Equivalent	Bio-Rad Laboratories
K121603	RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3	Nov 20, 2012	Substantially Equivalent	Randox Laboratories, Ltd.
K122838	LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK	Oct 17, 2012	Substantially Equivalent	Bio-Rad Laboratories
K113720	RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3	Sep 20, 2012	Substantially Equivalent	Randox Laboratories, Ltd.
K122291	THERMO SCIENTIFIC MAS OMNI-CARDIO	Aug 31, 2012	Substantially Equivalent	Microgenics Corporation
K121759	CONE-TROL LIQUID CHEMISTRY CONTROLS	Jul 24, 2012	Substantially Equivalent	Cone Bioproducts
K121794	LIQUICHEK URINE CHEMISTRY CONTROL	Jul 11, 2012	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K121468	EUROTROL GAS-ISE METABOLITES	Jun 22, 2012	Substantially Equivalent	Eurotrol B.V.
K112742	AUDIT MICROLQ SPINAL FLUID CONTROL	Jun 15, 2012	Substantially Equivalent	Aalto Scientific, Ltd.
K111964	AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY	Mar 02, 2012	Substantially Equivalent	Aalto Scientific, Ltd.
K112705	AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL	Jan 24, 2012	Substantially Equivalent	Aalto Scientific, Ltd.
K110534	RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3	Jan 23, 2012	Substantially Equivalent	Randox Laboratories Limited
K112337	RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL	Dec 01, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K101863	IT/IF CONTROL	Nov 07, 2011	Substantially Equivalent	Sebia
K110738	THERMO SCIENTIFIC MAS OMNI-CORE	Nov 03, 2011	Substantially Equivalent	Microgenics Corporation
K110904	RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3	Sep 30, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K111996	ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2	Sep 14, 2011	Substantially Equivalent	Elitechgroup
K111506	ELECSYS PRECICONTROL VARIA 3	Jul 08, 2011	Substantially Equivalent	Roche Diagnostics
K110880	VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT	Jul 05, 2011	Substantially Equivalent	Maine Standards Company, LLC
K110616	THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO	Jun 29, 2011	Substantially Equivalent	Microgenics Corp.
K111063	VITAL SERUM CONTROLS	Jun 28, 2011	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd
K103601	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	Jun 10, 2011	Substantially Equivalent	Aalto Scientific, Ltd.
K103364	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL	May 06, 2011	Substantially Equivalent	Diamond Diagnostics, Inc.
K103271	MSC LIPID CONTROL	Jan 25, 2011	Substantially Equivalent	Maine Standards Co.
K101216	AUDIT MICROCV PROTEIN LINEARITY SET	Jan 14, 2011	Substantially Equivalent	Aalto Scientific, Ltd.
K102617	AUDIT MICROCV CARDIAC MARKERS LINEARITY SET	Jan 10, 2011	Substantially Equivalent	Aalto Scientific, Ltd.
K102700	LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS	Dec 21, 2010	Substantially Equivalent	Alere, San Diego, Dba Biosite INcorporated, Dba IN
K101809	FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20	Oct 05, 2010	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K100727	LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK	Sep 14, 2010	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K100718	AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5	Sep 03, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K102016	PRECICONTROL CLINCHEM MULTI 1 AND 2	Sep 01, 2010	Substantially Equivalent	Roche Diagnostics
K101226	AUDIT MICROCV RF/CRP LINEARITY SET	Aug 31, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K102157	ELECSYS PRECICONTROL MULTIMARKER	Aug 27, 2010	Substantially Equivalent	Roche Diagnostics
K101633	NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH	Aug 27, 2010	Substantially Equivalent	Nova Biomedical Corp.
K093492	MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR	Mar 19, 2010	Substantially Equivalent	Diamond Diagnostics, Inc.
K093384	MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)	Mar 10, 2010	Substantially Equivalent	Diamond Diagnostics, Inc.
K093032	TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET	Nov 13, 2009	Substantially Equivalent	Biosite Incorporated
K092320	ELECSYS PRECICONTROL THYROAB	Nov 03, 2009	Substantially Equivalent	Roche Diagnostics
K092051	THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158	Sep 21, 2009	Substantially Equivalent	Microgenics Corp.
K090541	ELECSYS PRECICONTROL UNIVERSAL	Jul 02, 2009	Substantially Equivalent	Roche Diagnostics
K091225	VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET	Jun 25, 2009	Substantially Equivalent	Maine Standards Co.
K083554	CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3	Apr 21, 2009	Substantially Equivalent	Cliniqa Corporation
K090475	VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402	Apr 16, 2009	Substantially Equivalent	Maine Standards Co.
K083891	VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901	Mar 23, 2009	Substantially Equivalent	Maine Standards Co.
K082714	AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5	Nov 19, 2008	Substantially Equivalent	Aalto Scientific, Ltd.
K082717	AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5	Oct 30, 2008	Substantially Equivalent	Aalto Scientific, Ltd.
K082107	CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2	Sep 17, 2008	Substantially Equivalent	Cliniqa Corporation
K082036	LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK	Sep 08, 2008	Substantially Equivalent	Bio-Rad Laboratories
K082067	MSC LIPID CONTROL	Aug 22, 2008	Substantially Equivalent	Maine Standards Co.
K080973	CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC	Jun 02, 2008	Substantially Equivalent	Cliniqa Corporation
K073080	QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945	Jan 24, 2008	Substantially Equivalent	Bio-Rad Laboratories
K072835	LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK	Dec 11, 2007	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K072892	TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5	Dec 07, 2007	Substantially Equivalent	Biosite Incorporated
K072246	VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601	Sep 14, 2007	Substantially Equivalent	Maine Standards Co.
K071980	DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H	Sep 11, 2007	Substantially Equivalent	Dade Behring, Inc.
K071675	LIQUICHEK TUMOR MARKER CONTROL	Jul 03, 2007	Substantially Equivalent	Bio-Rad Laboratories
K071433	SMS GLUCOSE CONTROL, MODEL 2120059	Jun 28, 2007	Substantially Equivalent	Specialty Medical Supplies
K070741	CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3	May 04, 2007	Substantially Equivalent	Cliniqa Corporation
K070504	AMMONIA/ALCOHOL CONTROL SET	Apr 11, 2007	Substantially Equivalent	Pointe Scientific, Inc.,
K070200	TDM CONTROL SET, MODEL CAT# 04521536	Mar 19, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K070223	AUDIT MICROCV LIPIDS LINEARITY SET (LOW)	Mar 13, 2007	Substantially Equivalent	Aalto Scientific, Ltd.
K062379	COBAS INTEGRA CERULOPLASMIN	Jan 31, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K062674	MISSION TRINITY B	Dec 01, 2006	Substantially Equivalent	Diamond Diagnostics, Inc.
K062593	CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET	Nov 22, 2006	Substantially Equivalent	Compass Bioscience
K062916	CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3	Oct 23, 2006	Substantially Equivalent	Cliniqa Corporation
K062668	AUDIT MICROCV IMMUNOASSAY LINEARITY SET	Oct 16, 2006	Substantially Equivalent	Aalto Scientific, Ltd.
K061137	ADVIA IMS CPSA CONTROL	Jul 06, 2006	Substantially Equivalent	Bayer Healthcare, LLC
K061196	CARDIOIMMUNE XL CARDIAC MARKER CONTROL	May 30, 2006	Substantially Equivalent	Microgenics Corp.
K060850	NOD CHEMISTRY CONTROL	May 30, 2006	Substantially Equivalent	Bioresource Technology, Inc.
K061182	CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB	May 25, 2006	Substantially Equivalent	Cliniqa Corporation
K060206	MISSION COMPLETE	Mar 21, 2006	Substantially Equivalent	Diamond Diagnostics, Inc.
K060429	TDM CONTROL SET	Mar 15, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K053247	VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET	Jan 13, 2006	Substantially Equivalent	Maine Standards Co.
K051543	ELECSYS PRECICONTROL BONE	Oct 17, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K051928	AUTOCHECK6+	Oct 12, 2005	Substantially Equivalent	Radiometer Medical Aps
K052056	DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM	Sep 23, 2005	Substantially Equivalent	Thermo-Electron Corp.
K051687	ELECSYS PRECICONTROL UNIVERSAL	Jul 25, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K051185	ELECSYS CA 19-9 CALCHECK	Jul 06, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K051517	ELECSYS PRECICONTROL ANEMIA	Jul 05, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K050537	LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS	Apr 27, 2005	Substantially Equivalent	Bio-Rad
K050387	ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR	Apr 25, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K050504	VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS	Mar 25, 2005	Substantially Equivalent	Maine Standards Co.
K050536	QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL	Mar 24, 2005	Substantially Equivalent	Bio-Rad
K050125	RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4	Mar 18, 2005	Substantially Equivalent	More Diagnostics
K043208	LIQUID ASSAYED MULTIQUAL CONTROL	Jan 07, 2005	Substantially Equivalent	Bio-Rad
K042318	AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET	Dec 09, 2004	Substantially Equivalent	Aalto Scientific, Ltd.
K043108	LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL	Dec 07, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K042625	QUIKREAD CRP CALIBRATOR SET	Nov 18, 2004	Substantially Equivalent	Orion Diagnostica, OY
K042815	QUEST TUMOR MARKER CONTROL, MODEL 955	Nov 05, 2004	Substantially Equivalent	Bio-Rad
K041975	VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501	Oct 15, 2004	Substantially Equivalent	Maine Standards Co.
K042324	LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5	Oct 07, 2004	Substantially Equivalent	Bio-Rad
K042335	ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05	Sep 17, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K042389	MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA	Sep 14, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K041361	RANDOX TRI LEVEL CARDIAC CONTROL	Sep 09, 2004	Substantially Equivalent	Randox Laboratories Limited
K041812	MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)	Jul 27, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K040459	TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS	Jul 06, 2004	Substantially Equivalent	Biosite Incorporated
K040379	RANDOX IMMUNOASSAY CONTROL	Jun 16, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K041227	MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA	May 27, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K041073	DOCUMENT SALICYLATE CAL VER	May 21, 2004	Substantially Equivalent	Microgenics Corp.
K040822	LIQUICHEK TORCH PLUS IGM CONTROL	May 19, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K040925	NORMAL AND HYPERGAMMA CONTROL SERUM	Apr 28, 2004	Substantially Equivalent	Sebia
K040880	MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3	Apr 28, 2004	Substantially Equivalent	Medical Analysis Systems, Inc.
K040352	NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)	Apr 02, 2004	Substantially Equivalent	Bioresource Technology, Inc.
K040535	LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS	Mar 29, 2004	Substantially Equivalent	Cliniqa Corporation
K040280	PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS	Mar 11, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K040277	LIQUICHEK CARDIAC MARKER CONTROL LT	Mar 10, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K040273	LYPHOCHEK ASSAYED CHEMISTRY CONTROL	Mar 04, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K040091	LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS	Feb 23, 2004	Substantially Equivalent	Cliniqa Corporation
K033344	LIGAND PLUS CONTROL LEVEL 1-3	Jan 16, 2004	Substantially Equivalent	Consolidated Technology
K033937	ELECSYS PRECICONTROL MULTIANALYTE	Jan 07, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K033379	BAYER SPECIAL CHEMISTRY CONTROLS	Dec 19, 2003	Substantially Equivalent	Bayer Diagnostics Corp.
K033387	QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945	Dec 02, 2003	Substantially Equivalent	Bio-Rad
K032074	LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS	Oct 21, 2003	Substantially Equivalent	Cliniqa Corporation
K033162	LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS	Oct 10, 2003	Substantially Equivalent	Cliniqa Corporation
K032122	AUDIT MICROCONTROLS MICROFD BNP CONTROL	Sep 09, 2003	Substantially Equivalent	Aalto Scientific, Ltd.
K032237	N/T PROTEIN CONTROL	Sep 05, 2003	Substantially Equivalent	Dade Behring, Inc.
K032453	ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL	Aug 28, 2003	Substantially Equivalent	Bionostics, Inc.
K031921	LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS	Aug 25, 2003	Substantially Equivalent	Cliniqa Corporation
K032335	MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL	Aug 19, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K031577	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS	Aug 06, 2003	Substantially Equivalent	Cliniqa Corporation
K032089	ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC	Jul 30, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031575	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS	Jul 23, 2003	Substantially Equivalent	Cliniqa Corporation
K031644	BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL	Jun 25, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K031101	RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2	Jun 16, 2003	Substantially Equivalent	Hemagen Diagnostics, Inc.
K031364	MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3	May 30, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K030942	MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL	Apr 28, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K030801	BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL	Apr 09, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K030705	CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL	Mar 26, 2003	Substantially Equivalent	Cliniqa Corporation
K030482	WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553	Mar 19, 2003	Substantially Equivalent	Wiener Laboratories
K030679	MAS LIPID LEVEL 1 AND 2	Mar 14, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K030566	LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS	Mar 13, 2003	Substantially Equivalent	Cliniqa Corporation
K030452	BAYER LIGAND PLUS 1, 2, 3 CONTROLS	Mar 03, 2003	Substantially Equivalent	Bayer Diagnostics Corp.
K030150	LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS	Jan 28, 2003	Substantially Equivalent	Cliniqa Corporation
K030089	TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS	Jan 23, 2003	Substantially Equivalent	Biosite Incorporated
K030088	TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS	Jan 17, 2003	Substantially Equivalent	Biosite Incorporated
K023410	VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110	Jan 06, 2003	Substantially Equivalent	Maine Standards Co.
K023731	QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3	Dec 24, 2002	Substantially Equivalent	Consolidated Technology
K023669	MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA	Dec 19, 2002	Substantially Equivalent	Medical Analysis Systems, Inc.
K023867	MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3	Dec 17, 2002	Substantially Equivalent	Medical Analysis Systems, Inc.
K023661	LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS	Dec 06, 2002	Substantially Equivalent	Cliniqa Corporation
K023352	VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109	Nov 22, 2002	Substantially Equivalent	Maine Standards Co.
K023250	LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE	Oct 17, 2002	Substantially Equivalent	Cliniqa Corporation
K022936	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE	Oct 02, 2002	Substantially Equivalent	Cliniqa Corporation
K022885	LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE	Oct 02, 2002	Substantially Equivalent	Cliniqa Corporation
K022867	LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE	Oct 02, 2002	Substantially Equivalent	Cliniqa Corporation
K022851	PH AND AMINES EXTERNAL CONTROL SET	Sep 27, 2002	Substantially Equivalent	Quidel Corp.
K022991	LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596	Sep 17, 2002	Substantially Equivalent	Bio-Rad
K022591	RANDOX LIPID CONTROL	Aug 30, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K022401	PTS PANELS MULTI-CHEMISTRY CONTROLS	Aug 21, 2002	Substantially Equivalent	Polymer Technology Systems, Inc.
K022041	LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563	Jul 16, 2002	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K021930	MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL	Jun 25, 2002	Substantially Equivalent	Bionostics, Inc.
K021381	MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2	Jun 10, 2002	Substantially Equivalent	Dade Behring, Inc.
K020817	LIQUICHEK URINE CHEMISTRY CONTROL	Apr 12, 2002	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K020450	VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108	Mar 21, 2002	Substantially Equivalent	Maine Standards Co.
K020237	IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3	Mar 19, 2002	Substantially Equivalent	Consolidated Technology
K020521	MODIFICATION TO VIGIL LIPID CONTROL	Mar 01, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K013995	MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL	Dec 21, 2001	Substantially Equivalent	Medical Analysis Systems, Inc.
K013734	MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL	Dec 07, 2001	Substantially Equivalent	Medical Analysis Systems, Inc.
K013332	LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE	Nov 20, 2001	Substantially Equivalent	Cliniqa Corporation
K013265	VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007	Nov 20, 2001	Substantially Equivalent	Maine Standards Co.
K013235	MODIFICATION TO SYNCHRON CONTROL	Oct 16, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K012468	MODIFICATION TO N/T PROTEIN CONTROL SL	Sep 04, 2001	Substantially Equivalent	Dade Behring, Inc.
K012855	LIQUISPX LIQUID LIPID CONTROL	Aug 30, 2001	Substantially Equivalent	Clinical Controls Division
K012513	LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642	Aug 29, 2001	Substantially Equivalent	Bio-Rad
K012431	COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3	Aug 28, 2001	Substantially Equivalent	Bionostics, Inc.
K012243	MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL	Aug 20, 2001	Substantially Equivalent	Hematronix, Inc.
K012120	VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004	Aug 20, 2001	Substantially Equivalent	Maine Standards Co.
K012119	VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003	Aug 20, 2001	Substantially Equivalent	Maine Standards Co.
K012118	VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002	Aug 20, 2001	Substantially Equivalent	Maine Standards Co.
K012117	VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001	Aug 20, 2001	Substantially Equivalent	Maine Standards Co.
K011853	ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10	Jul 17, 2001	Substantially Equivalent	Bio-Rad
K011867	LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800	Jul 12, 2001	Substantially Equivalent	Bio-Rad
K011731	TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3	Jul 05, 2001	Substantially Equivalent	Medical Analysis Systems, Inc.
K011579	LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580	Jun 26, 2001	Substantially Equivalent	Bio-Rad
K011548	CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3	Jun 18, 2001	Substantially Equivalent	Medical Analysis Systems, Inc.
K011494	LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL	Jun 08, 2001	Substantially Equivalent	Bio-Rad
K011169	HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3	May 18, 2001	Substantially Equivalent	International Enzymes, Inc.
K010358	VIGIL SEROLOGY CONTROL LEVEL C	Mar 05, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010111	CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK	Feb 28, 2001	Substantially Equivalent	Medical Analysis Systems, Inc.
K003716	CONFORMANCE CHEMISTRY CONTROL C3	Dec 20, 2000	Substantially Equivalent	Consolidated Technology
K003488	SYNCHRON CONTROL	Nov 27, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K002852	N/T PROTEIN CONTROL SL	Nov 27, 2000	Substantially Equivalent	Dade Behring, Inc.
K001249	QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3	Nov 02, 2000	Substantially Equivalent	Consolidated Technologies of Wisconsin
K002460	LIQUICHEK LIPIDS CONTROL, MODEL 641, 642	Aug 31, 2000	Substantially Equivalent	Bio-Rad
K002174	DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3	Aug 22, 2000	Substantially Equivalent	Casco-Nerl Diagnostics Corporation (Maine)
K002196	LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483	Aug 07, 2000	Substantially Equivalent	Bio-Rad
K001758	DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)	Jul 05, 2000	Substantially Equivalent	Medical Analysis Systems, Inc.
K001632	OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009	Jun 19, 2000	Substantially Equivalent	Avl Scientific Corp.
K001373	LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363	May 25, 2000	Substantially Equivalent	Bio-Rad
K000875	ASSAYED QCS 1,2, CAT. NOS. 970200, 970500	Apr 20, 2000	Substantially Equivalent	Bio-Rad
K000810	QUALITROL LIPID CONTROL, LEVELS 1 AND 2	Apr 13, 2000	Substantially Equivalent	Consolidated Technologies of Wisconsin
K000270	ELECSYS CORTISOL TEST SYSTEM	Mar 07, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000116	QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3	Feb 15, 2000	Substantially Equivalent	Consolidated Technologies, Inc.
K981915	TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION	Dec 20, 1999	Substantially Equivalent	The Binding Site, Ltd.
K993631	QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2	Dec 09, 1999	Substantially Equivalent	Seracare Technology
K992939	QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3	Dec 09, 1999	Substantially Equivalent	Seracare Technology
K993546	TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3	Nov 30, 1999	Substantially Equivalent	Medical Analysis Systems, Inc.
K993310	APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH	Nov 30, 1999	Substantially Equivalent	Dade Behring, Inc.
K993023	SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS	Nov 26, 1999	Substantially Equivalent	Beckman Coulter, Inc.
K993014	MODIFICATION TO DOCUMENT THYROID CAL.VER	Nov 26, 1999	Substantially Equivalent	Casco-Nerl Diagnostics Corporation (Maine)
K993360	PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA	Nov 24, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K992900	PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA	Nov 24, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K992710	ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK	Nov 24, 1999	Substantially Equivalent	Abbott Laboratories
K992770	QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3	Nov 12, 1999	Substantially Equivalent	Seracare Technology
K992741	LYPHOCHEK ANEMIA CONTROL, MODEL 500	Nov 09, 1999	Substantially Equivalent	Bio-Rad
K992172	LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580	Sep 02, 1999	Substantially Equivalent	Bio-Rad
K992349	VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS	Aug 24, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K992550	LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3	Aug 11, 1999	Substantially Equivalent	Bio-Rad
K992034	DOCUMENT THYROID CAL*VER	Jul 23, 1999	Substantially Equivalent	Casco-Nerl Diagnostics Corporation (Maine)
K991704	N/T PROTEIN CONTROL LC	Jun 25, 1999	Substantially Equivalent	Dade Behring, Inc.
K991447	CARDIOQUANT CARDIAC ASSESSMENT CONTROLS	Jun 11, 1999	Substantially Equivalent	Spectral Diagnostics, Inc.
K991182	MODIFICATION OF N/T PROTEIN CONTROL SL	May 19, 1999	Substantially Equivalent	Dade Behring, Inc.
K990016	VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS	May 19, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K990610	ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10	Apr 27, 1999	Substantially Equivalent	Bio-Rad
K990888	MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752	Apr 07, 1999	Substantially Equivalent	Bio-Rad
K990424	ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01	Mar 31, 1999	Substantially Equivalent	Bio-Rad
K990394	ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02	Mar 18, 1999	Substantially Equivalent	Bio-Rad
K990317	ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01	Mar 18, 1999	Substantially Equivalent	Bio-Rad
K990391	ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01	Mar 15, 1999	Substantially Equivalent	Bio-Rad
K990531	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	Mar 12, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K990282	ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01	Mar 09, 1999	Substantially Equivalent	Bio-Rad
K984594	LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220	Feb 02, 1999	Substantially Equivalent	Bio-Rad
K984419	ELECSYS IGE CALCHECK	Feb 02, 1999	Substantially Equivalent	Boehringer Mannheim Corp.
K984477	LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529	Jan 29, 1999	Substantially Equivalent	Bio-Rad
K990161	ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01	Jan 28, 1999	Substantially Equivalent	Bio-Rad
K990150	ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01	Jan 26, 1999	Substantially Equivalent	Bio-Rad
K990149	ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01	Jan 26, 1999	Substantially Equivalent	Bio-Rad
K990017	ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10	Jan 25, 1999	Substantially Equivalent	Bio-Rad
K984325	ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05	Dec 17, 1998	Substantially Equivalent	Bio-Rad
K983807	LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580	Dec 16, 1998	Substantially Equivalent	Bio-Rad
K984372	ELECSYS CALCHECK TROPONIN T	Dec 14, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K984225	LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384	Dec 14, 1998	Substantially Equivalent	Bio-Rad
K984074	ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05	Nov 20, 1998	Substantially Equivalent	Bio-Rad
K983507	VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY	Nov 04, 1998	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K983513	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	Nov 03, 1998	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K983492	BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC	Oct 09, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K983241	ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	Sep 29, 1998	Substantially Equivalent	Kamiya Biomedical Co.
K983130	LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS	Sep 29, 1998	Substantially Equivalent	Kamiya Biomedical Co.
K983166	ELECSYS CALCHECK MYOGLOBIN	Sep 22, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982637	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	Aug 12, 1998	Substantially Equivalent	Diagnostic Products Corp.
K982473	TUMOR MARKER CONTROL	Aug 12, 1998	Substantially Equivalent	Diagnostic Products Corp.
K982290	CHEM-CHEX STAT (NEW)	Jul 22, 1998	Substantially Equivalent	Streck Laboratories, Inc.
K982224	VIGIL PROTEIN CONTROL	Jul 09, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K981401	BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS	May 18, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K981455	THIRD GENERATION PSA CONTROL MODULE	May 13, 1998	Substantially Equivalent	Diagnostic Products Corp.
K981532	LYPHOCHEK IMMUNOASSAY PLUS CONTROL	May 12, 1998	Substantially Equivalent	Bio-Rad
K981474	CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)	May 07, 1998	Substantially Equivalent	Spectral Diagnostics, Inc.
K981339	QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3	Apr 21, 1998	Substantially Equivalent	Consolidated Technologies, Inc.
K980514	CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002	Mar 04, 1998	Substantially Equivalent	Medical Analysis Systems, Inc.
K972904	DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL	Feb 20, 1998	Substantially Equivalent	Casco Standards
K980178	OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY	Feb 12, 1998	Substantially Equivalent	Bionostics, Inc.
K974613	VIROTROL III	Jan 27, 1998	Substantially Equivalent	Blackhawk Biosystems, Inc.
K974826	BM PRECIPATH(R) HDL/LDL-C CONTROL	Jan 22, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K974822	AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL	Jan 22, 1998	Substantially Equivalent	Avl Scientific Corp.
K974827	TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE	Jan 08, 1998	Substantially Equivalent	Biosite Incorporated
K974452	VIGIL LIPID CONTROL	Dec 17, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K974384	ELECSYS CALCHECK FOLATE	Dec 08, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K973894	IMMUSURE	Oct 29, 1997	Substantially Equivalent	Quantimetrix Corp.
K973791	ABC CALIBRATION VERIFIERS	Oct 14, 1997	Substantially Equivalent	Sc Calibrators & Controls, LLC
K973790	ABC LINEARITY VERIFIERS	Oct 14, 1997	Substantially Equivalent	Sc Calibrators & Controls, LLC
K973629	PRECINORM RF, PRECIPATH RF	Oct 07, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K973517	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	Sep 25, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K973469	QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS	Sep 25, 1997	Substantially Equivalent	Consolidated Technologies, Inc.
K973030	VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)	Sep 04, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K972868	TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL	Aug 28, 1997	Substantially Equivalent	Bionostics, Inc.
K972235	PRECICONTROL TUMOR MARKER 1 AND 2	Aug 12, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K972048	ACCURUN 117 HBEAG POSITIVE CONTROL	Aug 12, 1997	Substantially Equivalent	Boston Biomedica, Inc.
K971657	ACCURUN 121 HAV IGM POSITIVE CONTROL	Aug 12, 1997	Substantially Equivalent	Boston Biomedica, Inc.
K972307	ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL	Aug 07, 1997	Substantially Equivalent	Boston Biomedica, Inc.
K971406	ACCURUN 120 HAV IGG POSITIVE CONTROL	Aug 07, 1997	Substantially Equivalent	Boston Biomedica, Inc.
K972608	RANDOX ASSAYED SPECIFIC PROTEIN CONTROL	Aug 04, 1997	Substantially Equivalent	Randox Laboratories, Ltd.
K972070	NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS	Jun 26, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K972214	ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)	Jun 24, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K972080	QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3	Jun 18, 1997	Substantially Equivalent	Consolidated Technologies, Inc.
K971952	LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)	Jun 16, 1997	Substantially Equivalent	Bio-Rad
K971405	SPECIALITY URINE 1,2	Jun 16, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K971954	LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)	Jun 11, 1997	Substantially Equivalent	Bio-Rad
K971071	LIQUID LIGAND 1,2,3	Apr 23, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K970956	CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5	Apr 08, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K970862	SPINALSCOPICS	Apr 08, 1997	Substantially Equivalent	Quantimetrix Corp.
K970979	LIQUID CSF(LCR)1, LIQUID CSF(LCR)2	Apr 02, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K970976	CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3	Apr 02, 1997	Substantially Equivalent	Medical Analysis Systems, Inc.
K965114	TUMOR MARKER CONTROL	Feb 20, 1997	Substantially Equivalent	Diagnostic Products Corp.
K970147	ELECSYS CALCHECK PROLACTIN	Feb 10, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K965048	VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)	Jan 27, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K965171	LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)	Jan 13, 1997	Substantially Equivalent	Bio-Rad
K964640	CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92	Dec 13, 1996	Substantially Equivalent	Canyon Diagnostics, Inc.
K963770	BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS	Dec 05, 1996	Substantially Equivalent	Biocircuits Corp.
K964065	N/T PROTEIN CONTROL SL	Nov 06, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K961941	LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363	Sep 16, 1996	Substantially Equivalent	Bio-Rad
K961359	LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2	Sep 13, 1996	Substantially Equivalent	Bioprocessing, Inc.
K963346	STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3	Sep 09, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K962982	NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT	Aug 23, 1996	Substantially Equivalent	Nova Biomedical Corp.
K962997	NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3	Aug 15, 1996	Substantially Equivalent	Nova Biomedical Corp.
K961912	QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET	Aug 15, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K962630	DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL	Jul 22, 1996	Substantially Equivalent	Casco Standards
K962575	ELECSYS PRECICONTROL CARDIAC	Jul 22, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K961750	DOCUMENT CARDIAC ASSAYED CONTROL	Jul 22, 1996	Substantially Equivalent	Casco Standards
K961195	CHEM-CHEX STAT	May 15, 1996	Substantially Equivalent	Streck Laboratories, Inc.
K961293	QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2	May 02, 1996	Substantially Equivalent	Consolidated Technologies, Inc.
K955691	SERUM VOLATILES CONTROL LEVEL 1 & 2	Apr 24, 1996	Substantially Equivalent	Clinical Controls, Inc.
K955690	AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3	Apr 24, 1996	Substantially Equivalent	Clinical Controls, Inc.
K960824	IMMUNOLOGY CONTROL	Apr 23, 1996	Substantially Equivalent	Medical Analysis Systems, Inc.
K960862	LIPID CONTROL	Apr 03, 1996	Substantially Equivalent	Medical Analysis Systems, Inc.
K955812	SYSCON TURMOR MARKER CONTROL	Mar 12, 1996	Substantially Equivalent	Scantibodies Laboratory, Inc.
K955858	N/T PROTEIN CONTROL SY/L, M AND H	Feb 21, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K954247	SYSCON CONTROL ASSAYED & UNASSAYED	Feb 14, 1996	Substantially Equivalent	Scantibodies Laboratory, Inc.
K955264	NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2	Feb 02, 1996	Substantially Equivalent	Nova Biomedical Corp.
K955260	NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION	Feb 02, 1996	Substantially Equivalent	Nova Biomedical Corp.
K955252	NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4	Feb 02, 1996	Substantially Equivalent	Nova Biomedical Corp.
K954656	ROCHE CONTROL SERUM P	Dec 21, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K954655	ROCHE CONTROL SERUM N	Dec 21, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K955024	LIQUICHEK ETHANOL/AMMONIA CONTROL	Nov 28, 1995	Substantially Equivalent	Bio-Rad
K954323	MAS LIQUID URINALYSIS CONTROL	Nov 09, 1995	Substantially Equivalent	Medical Analysis Systems, Inc.
K954298	VIROTROL IV	Nov 01, 1995	Substantially Equivalent	Blackhawk Biosystems, Inc.
K954074	AALTO SCIENTIFIC LIQUID CARDIAC CONTROL	Oct 07, 1995	Substantially Equivalent	Aalto Scientific, Ltd.
K952385	HEMA-TROL Q-CHECK	Sep 25, 1995	Substantially Equivalent	Medical Specialties Intl., Inc.
K952877	CSF LIQUID CEREBROSPINAL FLUID CONTROL	Aug 24, 1995	Substantially Equivalent	Medical Analysis Systems, Inc.
K942647	COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI	Jul 12, 1995	Substantially Equivalent	Scantibodies Laboratory, Inc.
K950802	LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM	Jun 01, 1995	Substantially Equivalent	International Enzymes, Inc.
K943394	PROSTAT CONTROL	May 23, 1995	Substantially Equivalent	Quantimetrix Corp.
K945651	LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3	May 16, 1995	Substantially Equivalent	Bio-Rad
K951749	BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 3	May 15, 1995	Substantially Equivalent	Biocell Laboratories, Inc.
K951170	VIGIL MULTICHEK CONTROLS	Apr 20, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K950469	DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET	Apr 11, 1995	Substantially Equivalent	Casco Standards
K944728	BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL	Mar 23, 1995	Substantially Equivalent	Bioresource Technology, Inc.
K944525	LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3	Mar 21, 1995	Substantially Equivalent	Medical Analysis Systems, Inc.
K950326	KENLOR HUMAN SPINAL FLUID CONTROL	Mar 20, 1995	Substantially Equivalent	Kenlor Industries, Inc.
K942458	PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED	Mar 13, 1995	Substantially Equivalent	Randox Laboratories, Ltd.
K950399	RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL	Feb 22, 1995	Substantially Equivalent	Bionostics, Inc.
K946049	LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2	Feb 10, 1995	Substantially Equivalent	Clinical Controls, Inc.
K944455	QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)	Jan 17, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K944454	QUANITITATE GBCC VERIFIER SET	Jan 17, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K943729	DYE CHECK STRIPS 545-630	Dec 29, 1994	Substantially Equivalent	Awareness Technology, Inc.
K945315	DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL	Dec 09, 1994	Substantially Equivalent	Casco Standards
K944513	LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E	Dec 02, 1994	Substantially Equivalent	International Enzymes, Inc.
K944486	LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E	Dec 02, 1994	Substantially Equivalent	International Enzymes, Inc.
K944452	QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)	Dec 02, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K944059	PROCHEQ 1 & 2	Nov 15, 1994	Substantially Equivalent	Prisma Systems
K935599	HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3	Oct 31, 1994	Substantially Equivalent	Clinical Controls, Inc.
K942295	VIROTROL TORCH	Oct 07, 1994	Substantially Equivalent	Blackhawk Biosystems, Inc.
K936245	MULTI ANALYTE LINEARITY SET	Oct 04, 1994	Substantially Equivalent	Teco Diagnostics
K943754	BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT	Sep 14, 1994	Substantially Equivalent	Bionostics, Inc.
K943290	BILIRUBIN PLUS/PEDIATRIC CONTROLS	Sep 14, 1994	Substantially Equivalent	Medi-Tech, Inc.
K941328	TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2	Aug 18, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K941876	WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2	Jul 28, 1994	Substantially Equivalent	More Diagnostics
K941698	SERUM VOLATILES CONTROL - LEVELS 1 AND 2	Jul 28, 1994	Substantially Equivalent	More Diagnostics
K941115	ACS CARDIO-TROL CONTROL	Jul 20, 1994	Substantially Equivalent	Analytical Control Systems, Inc.
K941912	N/T PROTEIN CONTROL SY/L, M, AND H	Jun 16, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K936184	VIGIL PRX CHEMISTRY CONTROL	Apr 15, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K930534	TMC I, II	Apr 04, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K935219	FERTILITY PLUS 1, 2, 3	Mar 22, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K940397	ACS O DILVENT PROTEIN DILUTION MATRIX	Mar 11, 1994	Substantially Equivalent	Analytical Control Systems, Inc.
K933844	PARA 4 PLUS	Dec 27, 1993	Substantially Equivalent	Streck Laboratories, Inc.
K933437	DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3	Oct 28, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K934357	LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2	Oct 21, 1993	Substantially Equivalent	Bio-Rad
K934056	TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3	Oct 18, 1993	Substantially Equivalent	Medical Analysis Systems, Inc.
K933435	DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2	Sep 24, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K930850	BECKMAN VIGIL PLUS CONTROL	Sep 01, 1993	Substantially Equivalent	Beckman Instruments, Inc.
K933317	LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2	Aug 11, 1993	Substantially Equivalent	Bio-Rad
K924919	DADE(R) TUMOR MARKER CONTROL	Aug 05, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K931366	TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3	Jul 28, 1993	Substantially Equivalent	Medical Analysis Systems, Inc.
K932458	DOCUMENT ENZYME	Jun 29, 1993	Substantially Equivalent	Casco Standards
K932076	LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II	Jun 29, 1993	Substantially Equivalent	Bio-Rad
K923663	MULTITROL IMMUNOLOGY CONTROL	Jun 28, 1993	Substantially Equivalent	Behring Diagnostics, Inc.
K931373	ANALYZER: STAT PROFILE PLUS 10 ANALYZER	Jun 15, 1993	Substantially Equivalent	Nova Biomedical Corp.
K931139	DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET	May 12, 1993	Substantially Equivalent	Casco Standards
K925326	ELECTROPHORESIS CONTROL LEVEL 1	Mar 26, 1993	Substantially Equivalent	Seradyn, Inc.
K924802	CALIBRATION VERIFICATION KIT OR CVK	Mar 09, 1993	Substantially Equivalent	Radiometer America, Inc.
K925256	QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL	Mar 01, 1993	Substantially Equivalent	Quantimetrix Corp.
K924061	CANCER ANTIGEN CONTROL	Feb 23, 1993	Substantially Equivalent	Polymedco, Inc.
K926046	DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III	Jan 05, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K924915	SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479	Dec 18, 1992	Substantially Equivalent	Helena Laboratories
K923795	DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET	Nov 05, 1992	Substantially Equivalent	Casco Standards
K921477	I-STAT(TM) LEVELS 1,2,3 CONTROLS	Nov 02, 1992	Substantially Equivalent	I-Stat Corp.
K923633	MULTIQUAL ASSAY PRODUCTS	Oct 13, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K923632	MULTIQUAL UNASSAYED PRODUCTS	Oct 13, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K923740	KODAK AMERLITE TOTAL THYROID CONTROL SERA	Sep 25, 1992	Substantially Equivalent	Eastman Kodak Company
K920291	MONI-TROL-L AND MONI-TROL-XL	Sep 02, 1992	Substantially Equivalent	Medical Analysis Systems, Inc.
K923165	AMERLITE FREE THYROID CONTROL SERA LAN.4002	Aug 10, 1992	Substantially Equivalent	Eastman Kodak Company
K922046	LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3	Jul 10, 1992	Substantially Equivalent	Bio-Rad
K920636	DADE URINE CHEMISTRY CONTROL LEVELS I AND II	Jul 07, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K920927	KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024	Jun 19, 1992	Substantially Equivalent	Helena Laboratories
K921286	LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2	Jun 09, 1992	Substantially Equivalent	Bio-Rad
K920926	KEMTROL SERUM CONTROL-ABNORMAL	May 07, 1992	Substantially Equivalent	Helena Laboratories
K920940	AMERLITE FREE THYROID CONTROL SERA LAN.4002	Apr 17, 1992	Substantially Equivalent	Eastman Kodak Company
K920826	HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL	Apr 07, 1992	Substantially Equivalent	Eastman Kodak Company
K920350	CHEM-CHEM MULTI-ANALYTE (MODIFIED)	Mar 23, 1992	Substantially Equivalent	Streck Laboratories, Inc.
K914958	RIATRAC PLUS	Mar 18, 1992	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K914204	TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3	Mar 17, 1992	Substantially Equivalent	Medical Analysis Systems, Inc.
K914890	N/T PROTEIN CONTROL UY	Feb 06, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K914255	LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2	Jan 09, 1992	Substantially Equivalent	Bio-Rad
K915191	RAI-TROL ELEVATED LIPIDS CONTROL	Dec 18, 1991	Substantially Equivalent	Reagents Applications, Inc.
K914619	CVM	Nov 22, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K913133	CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)	Sep 27, 1991	Substantially Equivalent	Bionostics, Inc.
K913224	LIPID LINEARITY CONTROLS	Sep 25, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K913687	CHEM-CHEX	Sep 19, 1991	Substantially Equivalent	Streck Laboratories, Inc.
K912718	ENZYME LINEARITY CONTROL	Sep 06, 1991	Substantially Equivalent	Phoenix Diagnostics, Inc.
K912455	DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL	Aug 12, 1991	Substantially Equivalent	Baxter Healthcare Corp
K912725	TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL	Jul 30, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K912441	LINEARITY TEST KITS	Jul 17, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K911984	ANEMIA I, II	Jun 13, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K911854	DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL	Jun 10, 1991	Substantially Equivalent	Baxter Healthcare Corp
K911755	CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE	May 22, 1991	Substantially Equivalent	Bionostics, Inc.
K911803	HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED	May 15, 1991	Substantially Equivalent	Hichem Diagnostics
K910440	DOCUMENT REFLECTANCE II LINEARITY TEST SET	May 10, 1991	Substantially Equivalent	Casco Standards
K911171	ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K911169	ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K904989	CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II	Jan 23, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K905389	CHEM-CHEX LIPID	Dec 26, 1990	Substantially Equivalent	Streck Laboratories, Inc.
K904784	CHOLESTECH L.D.X. LEVEL 1 CONTROL	Dec 18, 1990	Substantially Equivalent	Cholestech Corp.
K904781	CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL	Dec 18, 1990	Substantially Equivalent	Cholestrech Corp.
K904872	HDL CHOLESTEROL CONTROL	Dec 07, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K902740	LDL-DIRECT CONTROLS	Dec 07, 1990	Substantially Equivalent	Isolab, Inc.
K904968	QCLYTE PROTEIN BASED ISE CONTROL	Dec 06, 1990	Substantially Equivalent	Baxter Healthcare Corp
K904829	ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL	Dec 06, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K904075	CLINICAL CHEMISTRY CONTROL	Dec 06, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K904768	KODATROL I AND II CONTROL AND DILUENT SET	Nov 09, 1990	Substantially Equivalent	Eastman Kodak Company
K904141	TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III	Nov 01, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K904099	URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS	Oct 26, 1990	Substantially Equivalent	Hichem Diagnostics
K904293	HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)	Oct 12, 1990	Substantially Equivalent	Hichem Diagnostics
K903933	DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2	Oct 04, 1990	Substantially Equivalent	Baxter Healthcare Corp
K903566	DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III	Sep 24, 1990	Substantially Equivalent	Baxter Healthcare Corp
K903407	AFFINITY HLH TEST SYSTEM	Sep 07, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K903338	KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL	Sep 07, 1990	Substantially Equivalent	Kenlor Industries, Inc.
K903310	CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR	Sep 07, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K902909	CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL	Aug 22, 1990	Substantially Equivalent	Creative Laboratory Products, Inc.
K903225	CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT	Aug 17, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K903190	MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY	Aug 17, 1990	Substantially Equivalent	Medical Analysis Systems, Inc.
K902616	BILIRUBIN CONTROL	Jul 19, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K902094	BLOOD GAS/ISE CONTROLS	Jul 19, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K902673	HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND	Jul 17, 1990	Substantially Equivalent	Hi Chem, Inc.
K902235	LVM QUALITY CONTROL SERUM	Jul 17, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K902573	PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM	Jul 10, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K902536	PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM	Jul 10, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K902095	BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS	Jun 12, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K901988	DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET	May 31, 1990	Substantially Equivalent	Casco Standards
K901212	LIG/TDM A, B, C	May 01, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K900717	TECHNICON TESTPOINT(TM) LIGAND CONTROL	Apr 26, 1990	Substantially Equivalent	Technicon Instruments Corp.
K901115	MULTICONSTITUENT SERUM RANGE LINEARITY #88234	Apr 19, 1990	Substantially Equivalent	Hichem Diagnostics
K900993	CHEM-CHEX	Apr 16, 1990	Substantially Equivalent	Streck Laboratories, Inc.
K892642	DADE(R) TDM CONTROL	Feb 02, 1990	Substantially Equivalent	Baxter Healthcare Corp
K895862	CLP NORMAL LIPID CONTROL	Jan 19, 1990	Substantially Equivalent	Creative Laboratory Products, Inc.
K895905	LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3	Jan 18, 1990	Substantially Equivalent	Bio-Rad
K896247	CLP COMPREHENSIVE LIPID CONTROL-HR	Jan 10, 1990	Substantially Equivalent	Creative Laboratory Products, Inc.
K896246	CLP COMPREHENSIVE LIPID CONTROL-LR	Jan 10, 1990	Substantially Equivalent	Creative Laboratory Products, Inc.
K896522	DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY	Jan 02, 1990	Substantially Equivalent	Casco Standards
K895943	NORMAL AND ABNORMAL CONTROL SERA	Dec 27, 1989	Substantially Equivalent	Sclavo, Inc.
K894852	SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS	Sep 28, 1989	Substantially Equivalent	Instrumentation Laboratory CO
K894078	LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II	Aug 11, 1989	Substantially Equivalent	Bio-Rad
K894252	LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM	Aug 01, 1989	Substantially Equivalent	Bio-Rad
K893580	DADE LIPID-TROL	Jul 20, 1989	Substantially Equivalent	Baxter Healthcare Corp
K893142	DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET	Jun 23, 1989	Substantially Equivalent	Casco Standards
K893141	DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET	Jun 23, 1989	Substantially Equivalent	Casco Standards
K891680	LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II	Jun 13, 1989	Substantially Equivalent	Bio-Rad
K891929	MONI-TROL(R)	May 09, 1989	Substantially Equivalent	Baxter Healthcare Corp
K890708	AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)	Mar 20, 1989	Substantially Equivalent	Amersham Corp.
K890470	RIATRAC PLUS	Mar 15, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K890414	RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)	Mar 15, 1989	Substantially Equivalent	Amersham Corp.
K890576	KENLOR HUMAN SPINAL FLUID CONTROL LIQUID	Mar 09, 1989	Substantially Equivalent	Kenlor Industries, Inc.
K890442	SHAPE-ACTIO URINALYSIS CONTROLS	Mar 08, 1989	Substantially Equivalent	Actio, Inc.
K884977	GAS TRAK PLUS	Jan 27, 1989	Substantially Equivalent	United Diagnostics, Inc.
K883942	HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL	Nov 10, 1988	Substantially Equivalent	Icl Scientific
K882486	LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II	Oct 25, 1988	Substantially Equivalent	Bio-Rad
K883861	DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST	Oct 13, 1988	Substantially Equivalent	Casco Standards
K882736	AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA	Oct 11, 1988	Substantially Equivalent	Amersham Corp.
K883147	TRACE ELEMENTS SERUM TOXICOLOGY CONTROL	Oct 06, 1988	Substantially Equivalent	Utak Laboratories, Inc.
K882728	AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190	Oct 06, 1988	Substantially Equivalent	Amersham Corp.
K883124	AMERLITE FREE THYROID CONTROL SERA LAN.4002	Sep 30, 1988	Substantially Equivalent	Amersham Corp.
K883247	LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL	Sep 13, 1988	Substantially Equivalent	Quantimetrix Medical Industries
K883012	A.QC CHEMISTRY CONTROL LEVEL 2	Sep 09, 1988	Substantially Equivalent	Arden Medical Systems, Inc.
K882727	AMERLITE TOTAL THYROID CONTROL SERA LAN.4001	Aug 08, 1988	Substantially Equivalent	Amersham Corp.
K882542	LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II	Jul 21, 1988	Substantially Equivalent	Bio-Rad
K881503	MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL	Jul 08, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881438	UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN	Jul 06, 1988	Substantially Equivalent	Hichem Diagnostics
K881437	CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS	Jul 06, 1988	Substantially Equivalent	Hichem Diagnostics
K881113	CLP LIPOPROTEIN ELECTROPHORESIS CONTROL	Jul 01, 1988	Substantially Equivalent	Creative Laboratory Products, Inc.
K881436	SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS	Jun 02, 1988	Substantially Equivalent	Hichem Diagnostics
K881229	AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693	May 27, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K880447	MULTI-FUNCTION BLOOD GAS CONTROL	May 27, 1988	Substantially Equivalent	Bionostics, Inc.
K881275	URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II	May 16, 1988	Substantially Equivalent	Fisher Scientific Co., LLC
K880494	LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)	Mar 03, 1988	Substantially Equivalent	Bio-Rad
K880175	DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL	Mar 01, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874731	LYPHOCHEK WHOLE BLOOD CONTROL	Feb 18, 1988	Substantially Equivalent	Bio-Rad
K874280	LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II	Jan 21, 1988	Substantially Equivalent	Bio-Rad
K874809	REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM	Jan 07, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K874810	REFERENCE ASSAYED CHEMISTRY CONTROL SERUM	Jan 05, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K874772	DC-TROL LEVEL 1 OR 2	Jan 05, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K874459	LIQUI-SERA SPINAL FLUID CONTROL	Dec 29, 1987	Substantially Equivalent	Biodiagnostic Intl
K874230	PRECINORM L	Nov 23, 1987	Substantially Equivalent	Boehringer Mannheim Corp.
K873611	A-QC CLINICAL CHEMISTRY CONTROL	Oct 20, 1987	Substantially Equivalent	Arden Medical Systems, Inc.
K872785	BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM	Aug 26, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K872777	BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL	Aug 26, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K872376	LIPID CONTROL SERUM	Aug 05, 1987	Substantially Equivalent	Biological Industries
K871977	DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR	Jul 09, 1987	Substantially Equivalent	American Dade
K872304	UNASSAYED CONTROL SERUM, NORMAL (BOVINE)	Jul 07, 1987	Substantially Equivalent	Vanguard Diagnostic Systems
K872303	UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)	Jul 07, 1987	Substantially Equivalent	Vanguard Diagnostic Systems
K872227	LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II	Jul 06, 1987	Substantially Equivalent	Bio-Rad
K871342	QM2/QM300 CONTROL A PACK	May 21, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871537	CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II	May 06, 1987	Substantially Equivalent	Canyon Diagnostics, Inc.
K871058	SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)	Apr 06, 1987	Substantially Equivalent	Fisher Scientific Co., LLC
K870684	LIQUID CHEMISTRY CONTROL, LEVEL I	Apr 06, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870683	LIQUID CHEMISTRY CONTROL, LEVEL II	Apr 06, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870252	DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET	Feb 20, 1987	Substantially Equivalent	Casco Standards
K862565	CHEMTROL(TM)	Jan 13, 1987	Substantially Equivalent	G.B.F. Industries, Inc.
K861202	TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS	Jan 09, 1987	Substantially Equivalent	Nms Pharmaceuticals, Inc.
K863849	LIQUI-SERA COMBO LIGAND/TDM CONTROLS	Nov 24, 1986	Substantially Equivalent	Biodiagnostic Intl
K863751	MULTI-ANALYTE LIN-TROL	Nov 24, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K863648	SERACON CT REFERENCE	Oct 29, 1986	Substantially Equivalent	Bhp Diagnostix, Inc.
K863745	ABNORMAL SPINAL FLUID CONTROL	Oct 07, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K861420	QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL	Sep 16, 1986	Substantially Equivalent	Quantimetrix Corp.
K862963	THERAPEUTIC DRUG MONITORING CONTROL SET	Sep 15, 1986	Substantially Equivalent	American Monitor Corp.
K862587	CHEMTROL(TM)	Aug 04, 1986	Substantially Equivalent	G.B.F. Industries, Inc.
K862586	CHEMVARION(TM)	Aug 04, 1986	Substantially Equivalent	G.B.F. Industries, Inc.
K862420	UTAK-STABBS TOXICOLOGY CONTROL	Aug 04, 1986	Substantially Equivalent	Utak Laboratories, Inc.
K862278	GAS-TRAK	Aug 04, 1986	Substantially Equivalent	United Diagnostics, Inc.
K862185	LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL	Aug 04, 1986	Substantially Equivalent	Bio-Rad
K860999	GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED	Jul 02, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K862179	SOMAS LIQUID URINE CONTROL	Jul 01, 1986	Substantially Equivalent	Somas Medical Industries, Inc.
K861901	MULTI-4 CO-OXIMETER CONTROL	Jun 17, 1986	Substantially Equivalent	Allied Instrumentation Laboratory
K860906	STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III	May 29, 1986	Substantially Equivalent	American Dade
K861603	IRON PROCEDURE	May 23, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861567	CONTROL SERA LEVEL VALUES (MG/DL)	May 23, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K861185	THERACHEM-PLUS, TRI-LEVEL TDC (TM)	May 23, 1986	Substantially Equivalent	Fisher Scientific Co., LLC
K860942	QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID	May 23, 1986	Substantially Equivalent	Quantimetrix Corp.
K861448	QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID	Apr 28, 1986	Substantially Equivalent	Quantimetrix Medical Industries
K861068	GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED	Apr 07, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K861000	GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED	Apr 03, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K860998	GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED	Apr 03, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K860970	PRECINORM IM AND PRECIPATH IM	Apr 03, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K860355	BOVINE CHEMISTRY CONTROL I.X AND II.X	Mar 17, 1986	Substantially Equivalent	American Dade
K855036	CHEMISTRY CONTROL N & A	Mar 17, 1986	Substantially Equivalent	Integrated Medical Systems Int'L., Inc.
K855035	CALIBRATION REFERENCE I & II	Mar 17, 1986	Substantially Equivalent	Integrated Medical Systems Int'L., Inc.
K854931	CANTROL ELECTROPHORESIS CONTROL	Jan 17, 1986	Substantially Equivalent	Canyon Diagnostics, Inc.
K854789	RANGE-CHEK	Jan 13, 1986	Substantially Equivalent	American Monitor Corp.
K854967	CRITIC - SF, ASSAYED	Jan 07, 1986	Substantially Equivalent	Dimension Diagnostics
K853943	CRITIC C LEVEL I & II	Dec 23, 1985	Substantially Equivalent	Dimension Diagnostics
K854119	ACCURACY	Oct 25, 1985	Substantially Equivalent	Columbia Diagnostics, Inc.
K853931	QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL	Oct 04, 1985	Substantially Equivalent	Quantimetrix Corp.
K853906	LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)	Oct 04, 1985	Substantially Equivalent	Biodiagnostic Intl
K852753	DC LIQUITROL LEVEL 1 & 2	Aug 02, 1985	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K852418	QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)	Jul 15, 1985	Substantially Equivalent	Amf Biological and Diagnostics Co.
K851820	SPINAL FLUID CONTROL	Jul 15, 1985	Substantially Equivalent	Irvine Scientific
K852594	DC-LIP, CATALOGUE NUMBER SE-020	Jul 12, 1985	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K851942	COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY	May 31, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K850574	DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO	Apr 12, 1985	Substantially Equivalent	American Dade
K850575	DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H	Apr 10, 1985	Substantially Equivalent	American Dade
K850017	PRECINORM H & PRECIPATH H	Mar 05, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K844848	IMA-TROL IMMUNOASSAY CONTROL	Mar 01, 1985	Substantially Equivalent	Dimension Diagnostics
K844413	ULTROSER G	Feb 27, 1985	Substantially Equivalent	Lkb Instruments, Inc.
K850202	GELMAN TRIPHOR CONTROL	Feb 06, 1985	Substantially Equivalent	Gelman Sciences, Inc.
K844996	PARAGON TRICHECK ELECTROPHORESIS CONTROL	Feb 06, 1985	Substantially Equivalent	Beckman Instruments, Inc.
K844760	UROL-QUAL	Jan 08, 1985	Substantially Equivalent	Dimension Diagnostics
K844125	LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN	Jan 08, 1985	Substantially Equivalent	Bio-Rad
K844018	GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3	Nov 27, 1984	Substantially Equivalent	United Diagnostics, Inc.
K843986	STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3	Nov 27, 1984	Substantially Equivalent	United Diagnostics, Inc.
K843611	QUALIFY I & II AMER. MONITOR 2009 & 2010	Sep 28, 1984	Substantially Equivalent	American Monitor Corp.
K842970	ALLERGENTICS TOTAL IGE/THEOPHYLLINE	Aug 29, 1984	Substantially Equivalent	Allergenetics
K841884	KODAK EKTACHEM CONTROL	Jul 06, 1984	Substantially Equivalent	Eastman Kodak Company
K841452	NOVA STAT CONTROL LEVELS 1/2/3	Jun 22, 1984	Substantially Equivalent	Nova Biomedical Corp.
K840458	BIOTIS ABNORMAL CLINICAL CHEM SERUM-	Apr 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840457	NORMAL CLINICAL CHEM. CONTROL SERUM-	Apr 13, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834064	ORTHO BI-LEVEL RECEPTOR CONTROL	Mar 23, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K833009	OMNI-FAL I & II	Jan 13, 1984	Substantially Equivalent	American Monitor Corp.
K833639	TITANGEL HIGH RESOLUTION CONTROL	Jan 04, 1984	Substantially Equivalent	Helena Laboratories
K833423	VENTREZYME EIA CONTROLS-IMMUNOASSAY	Dec 08, 1983	Substantially Equivalent	Ventrex Laboratories, Inc.
K833192	NORMAL URINE CONTROL	Dec 08, 1983	Substantially Equivalent	Biosan Laboratories, Inc.
K833191	ABNORMAL URINE CONTROL	Dec 08, 1983	Substantially Equivalent	Biosan Laboratories, Inc.
K831263	ELECTROPHORESIS CONTROLS-3 IN 1	Jul 07, 1983	Substantially Equivalent	Corning Medical & Scientific
K830179	BIOCELL SPINAL FLUID CONTROL	Feb 18, 1983	Substantially Equivalent	Biocell Laboratories, Inc.
K823352	IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS	Feb 07, 1983	Substantially Equivalent	American Dade
K823929	MULTIANALYTE CONTROLS-ALL KINDS	Jan 28, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K823490	ORTHO BI-LEVEL ASSAYED LIPID PROFILE	Jan 05, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K822850	MONI-TRO ES CHEMISTRY CONTROL LEVEL IX	Oct 27, 1982	Substantially Equivalent	American Dade
K821982	TITAN GEL SERUM CONTROL	Aug 16, 1982	Substantially Equivalent	Helena Laboratories
K821026	BI-LEVEL ASSAYED TUMOR MARKER & ANTIN	Aug 10, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K822133	IGE/THE OPHYLLINE CONTROL SERUM I,II,III	Aug 03, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K821560	LEVEL II LIPID CONTROL	Jul 13, 1982	Substantially Equivalent	Irvine Scientific
K821559	LEVEL I LIPID CONTROL	Jul 13, 1982	Substantially Equivalent	Irvine Scientific
K821557	LEVEL I CONTROL SERUM	Jul 08, 1982	Substantially Equivalent	Irvine Scientific
K821382	CHEMISTRY CONTROL/STANDARD	May 28, 1982	Substantially Equivalent	Medical Analysis Systems, Inc.
K821242	RESPONSE LIQUID LIGAND ASSAY SERUM	May 21, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K820255	BI-LEVEL ASSAYED URINE METAL CONTROL	Feb 18, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813580	Q-LINE LTC	Jan 18, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K813322	ORTHO* UNASSAYED CONTROL SERUM LEVEL III	Dec 17, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813321	ORTHO* UNASSAYED CONTROL SERUM LEVEL I	Dec 17, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813295	ORTHO CO2 DILUENT LEVEL III	Dec 17, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813294	ORTHO CO2 DILUENT LEVEL II	Dec 17, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813293	ORTHO CO2 DILUENT LEVEL I	Dec 17, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K813167	ORTHO UNASSAYED CONTROL SERUM LEVEL II	Nov 24, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K812556	DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C	Nov 02, 1981	Substantially Equivalent	American Dade
K812650	BECKMAN ICS NORMAL CONTROL SERA	Oct 19, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K812635	ANEMIA CONTROL	Oct 02, 1981	Substantially Equivalent	Environmental Chemical Specialties
K812583	BOVINE CHEMISTRY CONTROL I.X. & II.X.	Sep 24, 1981	Substantially Equivalent	American Dade
K811695	HELENA FETAL-TEK 200 MARKER	Jul 01, 1981	Substantially Equivalent	Helena Laboratories
K811467	DOXEPIN/DESMETHLDOXEPIN/LITHIUM	Jun 12, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K811466	AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM	Jun 12, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K811465	IMIPRAMINE/DISIPRAMINE/LITHIUM	Jun 12, 1981	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K811182	MULTIANALYTE CONTROLS, ALL KINDS	May 15, 1981	Substantially Equivalent	Fisher Scientific Co., LLC
K811100	GELMAN ELECTROPHORESIS CONTROL	May 01, 1981	Substantially Equivalent	Gelman Sciences, Inc.
K810952	CORNING VITAMIN B12 FOLATE DEFIC. CONTR.	Apr 17, 1981	Substantially Equivalent	Corning Medical & Scientific
K810906	TRI-LEVEL NDI CONTROL	Apr 14, 1981	Substantially Equivalent	Nuclear Diagnostics, Inc.
K803098	TRI-LEVEL RADIOASSAY CONTROL SERA	Jan 09, 1981	Substantially Equivalent	American Diagnostic Corp.
K802962	CHEM-ASSAY STANDARD-CONTROLS	Dec 22, 1980	Substantially Equivalent	National Bio-Technical Laboratories
K802109	KEMTROL SERUM CONTROL ABNORMAL	Oct 10, 1980	Substantially Equivalent	Helena Laboratories
K802108	KEMTROL SERUM CONTROL-NORMAL	Oct 10, 1980	Substantially Equivalent	Helena Laboratories
K801539	ASSURE LEVEL II PROD. #30172	Sep 09, 1980	Substantially Equivalent	Warner-Lambert Co.
K801538	ASSURE LEVEL I PROD. #30171	Sep 09, 1980	Substantially Equivalent	Warner-Lambert Co.
K801335	UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE	Jul 08, 1980	Substantially Equivalent	Warner-Lambert Co.
K800813	DIAGNOSTIC PRODUCTS CORP. RIA CONTROL	Apr 24, 1980	Substantially Equivalent	Diagnostic Products Corp.
K800559	SERTROL PRODUCT # ACS ST 101	Mar 25, 1980	Substantially Equivalent	Analytical Control Systems, Inc.
K800558	LIPID CONTROL PRODUCT # ACS LC 101	Mar 25, 1980	Substantially Equivalent	Analytical Control Systems, Inc.
K800370	CK/LD ISOENZYME CONTROL PROD. #ACS CT101	Mar 12, 1980	Substantially Equivalent	Analytical Control Systems, Inc.
K792375	ELEVATED LIPID CONTROL	Dec 06, 1979	Substantially Equivalent	Environmental Chemical Specialties
K792025	LYOPHILIZED HDL CHOLESTEROL CONTROLS	Oct 30, 1979	Substantially Equivalent	Helena Laboratories
K792024	LIPOTROL	Oct 30, 1979	Substantially Equivalent	Helena Laboratories
K791958	SERACON - EL DO27	Oct 17, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K791825	LY-PRO-TROL #ACS-LP101	Oct 01, 1979	Substantially Equivalent	Analytical Control Systems, Inc.
K791696	CONTRO II	Sep 24, 1979	Substantially Equivalent	Hi Chem, Inc.
K791695	CONTRO I	Sep 24, 1979	Substantially Equivalent	Hi Chem, Inc.
K791654	NORMAL CONTROL	Sep 17, 1979	Substantially Equivalent	Electrophoresis Corp. of America
K791313	ARS, CHEMISTRY	Aug 16, 1979	Substantially Equivalent	Mid Tech, Inc.
K791119	MACOMB NORMAL CONTROL SERUM	Jul 30, 1979	Substantially Equivalent	Macomb Chemical Co.
K790840	THYROID CONTROL SERA CODE QAS.101	Jun 28, 1979	Substantially Equivalent	Amersham Corp.
K790371	MACOMB LIPID CONTROL	Apr 04, 1979	Substantially Equivalent	Macomb Chemical Co.
K790264	DATA-TOPE TRI-RAC RADIOASSAY CONTROL	Mar 21, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K790330	CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN	Mar 15, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K782038	SERACON-C	Feb 08, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K781893	CONTROL, PROTEIN ELECTROPHORESIS	Dec 20, 1978	Substantially Equivalent	Sigma Chemical Co.
K781593	RIA CONTROLS	Oct 17, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K780552	COMP. CLIN. CHEM. CONTROL SERUM-DECISION	May 19, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K780351	NORMAL UNASSAYED CONTROL SERA	Apr 24, 1978	Substantially Equivalent	Macomb Chemical Co.
K780096	LDH ISOENZYME CONTROL SERUM	Mar 03, 1978	Substantially Equivalent	Worthington Biochemical Corp.
K771437	SERONORM LIPID	Sep 02, 1977	Substantially Equivalent	Nyegaard & Co. A/S
K770380	CHEMISTRY CONTROL-LOW & HIGH TQC TM	Apr 15, 1977	Substantially Equivalent	Technicon Instruments Corp.
K770312	CHEMISTRY CONTROL, ABNORMAL	Apr 05, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K770310	CHEMISTRY CONTROL, NORMAL	Apr 05, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K760818	TRIS BICARBONATE DILUENT	Nov 05, 1976	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories