Product Code: JIX FDA class 2 21 CFR 862.1150

Calibrator, Multi-Analyte Mixture

Clinical Chemistry

This device is a multi-analyte mixture calibrator used in clinical chemistry systems to simultaneously calibrate an analyzer across multiple measurands in a single calibration run, improving workflow efficiency in high-throughput laboratory settings. It is classified as FDA Class 2, meaning it requires 510(k) premarket notification to establish substantial equivalence before commercial distribution. The product code is JIX, regulated under 21 CFR 862.1150, and belongs to the Clinical Chemistry medical specialty.

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510(k)s

302

FEI Numbers

101

Registration Numbers

101

Unique Applicants

106

Years Active

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Basic Information

Product Code: JIX
Device Class: FDA class 2
Regulation Number: 862.1150
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 302 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K161140	VITROS Chemistry Products Calibrator Kit 3	May 20, 2016	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K153365	ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator	Dec 18, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K151552	ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II	Jul 08, 2015	Substantially Equivalent	Elitechgroup
K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)	Jun 15, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics
K141388	SYSTEM CALIBRATER	Jul 11, 2014	Substantially Equivalent	Beckman Coulter Ireland, Inc.
K133330	C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN	Nov 26, 2013	Substantially Equivalent	Roche Diagnostics
K130765	ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II	Apr 04, 2013	Substantially Equivalent	Elitechgroup
K123321	DIMENSION CHEMISTRY III CALIBRATORY	Feb 15, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics
K123372	ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR	Jan 14, 2013	Substantially Equivalent	Abbott Laboratories
K122398	RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS	Oct 12, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K112834	MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES	Mar 28, 2012	Substantially Equivalent	Verichem Laboratories, Inc.
K112029	ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05	Aug 30, 2011	Substantially Equivalent	Elitechgroup
K110394	ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)	Jun 09, 2011	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd
K110251	SYNCHRON MULTI CALIBRATOR	May 25, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K103701	ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS	Feb 18, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K103171	ELECSYS ANTI-TPO CALSET	Feb 11, 2011	Substantially Equivalent	Roche Diagnostics
K103403	MULTICONSTITUENT CALIBRATOR	Feb 04, 2011	Substantially Equivalent	Abbott Laboratories
K103612	DIMENSION VISA ENZ 2 CAL	Jan 25, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K101456	ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM	Sep 08, 2010	Substantially Equivalent	Roche Diagnostics
K101460	LOCI 8 CALIBRATOR, MODEL KC 646	Jul 09, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K100778	DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A	May 05, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K093732	ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770	Mar 22, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K093645	EXL ANEM CAL, MODEL RC640	Mar 05, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K092113	STA - FREE PS CALIBRATOR	Nov 13, 2009	Substantially Equivalent	Diagnostica Stago, Inc.
K090283	CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3	Jun 05, 2009	Substantially Equivalent	Genchem, Inc.
K080404	EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR	Mar 13, 2009	Substantially Equivalent	Medica Corp.
K083579	DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360	Feb 20, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K081533	SENTINEL PLASMAPROTEINS CAL 3X	Jun 25, 2008	Substantially Equivalent	SENTINEL CH. SpA
K081103	LOCI THYROID CALIBRATOR WITH MODEL RC610	May 23, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K073612	URIC ACID (AOX), SCAL, NORTROL, ABTROL	May 23, 2008	Substantially Equivalent	Thermofisher Scientific OY
K080607	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160	May 12, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K071779	ABX PENTRA URINE CAL	Mar 05, 2008	Substantially Equivalent	Horiba Abx
K072435	DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H	Oct 17, 2007	Substantially Equivalent	Dade Behring, Inc.
K072204	ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS	Oct 05, 2007	Substantially Equivalent	Siemens Medical Solutions Diagnostics
K071801	VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659	Jul 20, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K070971	MODIFICATION TO SENTINEL CLIN CHEM CAL	May 23, 2007	Substantially Equivalent	Sentinel Ch. Srl
K070207	MULTI-ANALYTE CHEMISTRY CALIBRATOR	Apr 13, 2007	Substantially Equivalent	Pointe Scientific, Inc.,
K063508	DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN	Jan 23, 2007	Substantially Equivalent	Dade Behring, Inc.
K062035	DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL	Oct 04, 2006	Substantially Equivalent	Dade Behring, Inc.
K062334	DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130	Sep 22, 2006	Substantially Equivalent	Dade Behring, Inc.
K062319	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360	Sep 13, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K062034	DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)	Sep 06, 2006	Substantially Equivalent	Dade Behring, Inc.
K062122	DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)	Aug 25, 2006	Substantially Equivalent	Dade Behring, Inc.
K061923	DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)	Aug 25, 2006	Substantially Equivalent	Dade Behring, Inc.
K061838	DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110	Aug 21, 2006	Substantially Equivalent	Dade Behring, Inc.
K061750	DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220	Aug 11, 2006	Substantially Equivalent	Dade Behring, Inc.
K062055	DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH	Aug 07, 2006	Substantially Equivalent	Dade Behring, Inc.
K061703	DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)	Aug 02, 2006	Substantially Equivalent	Dade Behring, Inc.
K061056	RANDOX LIQUID PROTEIN CALIBRATOR	Jul 20, 2006	Substantially Equivalent	Randox Laboratories, Ltd.
K061390	DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320	Jul 05, 2006	Substantially Equivalent	Dade Behring, Inc.
K061218	DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140	Jun 30, 2006	Substantially Equivalent	Dade Behring, Inc.
K060940	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III	Apr 24, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K053153	RANDOX CALIBRATION SERUM	Jan 13, 2006	Substantially Equivalent	Randox Laboratories, Ltd.
K051452	SENTINEL CLIN CHEM CAL	Oct 25, 2005	Substantially Equivalent	Sentinel Ch. Srl
K051619	LIPOPROTEIN FOR MULTIPLE ANALYTES	Aug 01, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K051457	SENTINEL PLASMAPROTEINS CAL 3X	Jul 25, 2005	Substantially Equivalent	Sentinel Ch. Srl
K050026	PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC	Jan 31, 2005	Substantially Equivalent	Roche Diagnostics
K043460	OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071	Jan 31, 2005	Substantially Equivalent	Olympus America, Inc.
K041926	HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278	Nov 23, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K042551	MULTI-CHEM CALIBRATOR A	Nov 16, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K042550	MULTI-LIPID CALIBRATOR	Nov 08, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K042549	MULTI CHEM CAL B	Nov 08, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K042243	MICROALBUMIN MULTI-CALIBRATOR SET	Oct 04, 2004	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K041905	HEMOSIL CALIBRATION PLASMA	Sep 28, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K041870	N APOLIPOPROTEIN STANDARD SERUM	Jul 27, 2004	Substantially Equivalent	Dade Behring, Inc.
K040264	CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF	Apr 02, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K040245	CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)	Mar 24, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K032936	DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR	Mar 12, 2004	Substantially Equivalent	Stanbio Laboratory
K033873	ELECSYS C-PEPTIDE CALSET	Feb 13, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K033791	BAYER SPECIFIC PROTEIN REFERENCE SERUM	Feb 13, 2004	Substantially Equivalent	Bayer Healthcare, LLC
K033910	OLYMPUS URINE CALIBRATOR	Jan 30, 2004	Substantially Equivalent	Cliniqa Corporation
K033380	BAYER SPECIAL CHEMISTRY CALIBRATORS	Dec 16, 2003	Substantially Equivalent	Bayer Diagnostics Corp.
K032665	OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071	Nov 21, 2003	Substantially Equivalent	Olympus America, Inc.
K033501	MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)	Nov 20, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K033061	CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE	Nov 07, 2003	Substantially Equivalent	Diamond Diagnostics, Inc.
K032287	MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2	Aug 18, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K031608	RANDOX LIQUID PROTEIN CALIBRATOR	Aug 08, 2003	Substantially Equivalent	Randox Laboratories, Ltd.
K031683	TOX AMMONIA CALIBRATOR	Aug 06, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K031880	AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL	Jul 16, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031682	LIPOPROTEIN CALIBRATOR	Jun 25, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K030804	BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR	Apr 10, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K030621	ATAC CALIBRATOR	Mar 19, 2003	Substantially Equivalent	Elan Diagnostics
K024305	WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006	Mar 18, 2003	Substantially Equivalent	Wiener Laboratories Saic
K030169	SETPOINT CHEMISTRY CALIBRATOR	Jan 31, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K023792	CALIBRATION PACK, MODELS A9100-101S AND A9100-103S	Jan 31, 2003	Substantially Equivalent	Thermo Orion
K030074	LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS	Jan 21, 2003	Substantially Equivalent	Cliniqa Corporation
K023876	VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1	Dec 10, 2002	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K023268	PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS	Nov 15, 2002	Substantially Equivalent	Phoenix Diagnostics, Inc.
K023158	RANDOX APOLIPOPROTEIN CALIBRATOR	Oct 24, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K022767	RAICHEM LIPID CALIBRATOR	Sep 03, 2002	Substantially Equivalent	Hemagen Diagnostics, Inc.
K022108	THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050	Jul 25, 2002	Substantially Equivalent	Thermo Dma, Inc.
K013397	PACIFIC HEMOSTASIS REFERENCE EMULSION	Feb 15, 2002	Substantially Equivalent	Fisher Diagnostics
K020129	PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE	Feb 01, 2002	Substantially Equivalent	Phoenix Diagnostics, Inc.
K013178	DC-UIBC-CO2-CAL, MODEL SE-153	Dec 18, 2001	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K012987	PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER	Nov 07, 2001	Substantially Equivalent	Phoenix Diagnostics, Inc.
K012509	PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM	Oct 09, 2001	Substantially Equivalent	Phoenix Diagnostics, Inc.
K012470	MODIFICATION TO N PROTEIN STANDARD SL	Sep 28, 2001	Substantially Equivalent	Dade Behring, Inc.
K012250	RAICHEM MULTI-ANALYTE CALIBRATOR	Sep 24, 2001	Substantially Equivalent	Hemagen Diagnostics, Inc.
K011658	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS	Jul 31, 2001	Substantially Equivalent	Rochdiag
K011226	CALIBRATOR FOR AUTOMATED SYSTEMS	Jun 25, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K011035	DIMENSION DRUG CALIBRATOR, MODEL DC22B	Jun 14, 2001	Substantially Equivalent	Dade Behring, Inc.
K010652	SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936	Mar 30, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K010030	LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR	Feb 14, 2001	Substantially Equivalent	Synergent Biochem Inc.-Clinical Controls Div.
K002804	N PROTEIN STANDARD SL	Oct 05, 2000	Substantially Equivalent	Dade Behring, Inc.
K001484	CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838	Jun 19, 2000	Substantially Equivalent	Alko Diagnostic Corp.
K000576	ELECSYS CORTISOL CALCHECK	Mar 21, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K993853	K-ASSAY MULTI-ANALYTE CALIBRATOR	Dec 27, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K993606	K-ASSAY APO A1/B CALIBRATOR SET	Nov 26, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K992845	HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT	Oct 18, 1999	Substantially Equivalent	Elan Holdings, Inc.
K993098	HDL-C/LDL-C CALIBRATOR, MODEL 1913-003	Oct 08, 1999	Substantially Equivalent	Data Medical Associates, Inc.
K992086	OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2	Aug 19, 1999	Substantially Equivalent	Olympus America, Inc.
K991166	K-ASSAY MICROALBUMIN CALIBRATOR SET	Jun 10, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K991181	MODIFICATION OF N PROTEIN STANDARD SL	Jun 01, 1999	Substantially Equivalent	Dade Behring, Inc.
K990460	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)	Mar 22, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K984425	MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR	Jan 20, 1999	Substantially Equivalent	Boehringer Mannheim Corp.
K984014	SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2	Dec 23, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K983469	PRECISET SERUM PROTEINS CALIBRATOR	Nov 25, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982767	RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR	Sep 21, 1998	Substantially Equivalent	Raichem
K982501	ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44	Sep 01, 1998	Substantially Equivalent	Alko Diagnostic Corp.
K981706	AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2	Jul 09, 1998	Substantially Equivalent	Abbott Laboratories
K981795	CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO	Jun 12, 1998	Substantially Equivalent	Thermo Bioanalysis Corp.
K981305	OLYMPUS SERUM PROTEIN MULTICALIBRATOR	May 07, 1998	Substantially Equivalent	Olympus America, Inc.
K981436	DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109	Apr 24, 1998	Substantially Equivalent	Casco Standards
K974825	BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS	Jan 30, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K974290	MICROPROTEIN STANDARD KIT	Dec 19, 1997	Substantially Equivalent	Verichem Laboratories, Inc.
K973932	BECKMAN CALIBRATOR 2 (CAL2)	Dec 15, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K973928	BECKMAN URINE PROTEIN CALIBRATOR (UCAL)	Dec 01, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K973345	MATRIX PLUS MULTI-CALIBRATOR KIT	Oct 29, 1997	Substantially Equivalent	Verichem Laboratories, Inc.
K972333	AMMONIA/IRON STANDARD KIT	Jul 23, 1997	Substantially Equivalent	Verichem Laboratories, Inc.
K971283	SYNCHRON SYSTEMS CAL 5 PLUS	Jun 03, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K971333	SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD	May 23, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K970921	STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)	Apr 08, 1997	Substantially Equivalent	Alko Diagnostic Corp.
K964527	N RHEUMATOLOGY STANDARD SL	Jan 15, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K964829	ELECSYS CALCHECK FSH	Dec 16, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K964062	N PROTEIN STRANDARD SL	Nov 21, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K963543	SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2	Oct 30, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K963533	SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1	Oct 29, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K962269	CEDIA CARDIAC TDM MULTI-CALS	Oct 29, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962629	DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR	Sep 13, 1996	Substantially Equivalent	Casco Standards
K962410	N PROTEIN STANDARD PY	Jul 16, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K962406	N CRP STANDARD SY	Jul 16, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K955489	CALIBRATION SERUM LEVEL 1 & 2	Jun 21, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K961659	CEDIA CORE TDM MULTI-CAL	Jun 13, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K960103	DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS	Apr 26, 1996	Substantially Equivalent	Dade Intl., Inc.
K960085	ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS	Mar 11, 1996	Substantially Equivalent	Alko Diagnostic Corp.
K955154	CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT	Dec 11, 1995	Substantially Equivalent	Alko Diagnostic Corp.
K953979	APOLIPOPROTEIN CALIBRATOR (APO-CAL)	Oct 03, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K942706	ROCHE CALIBRATOR SERUM	Sep 20, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K952282	ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR	Sep 15, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K953863	HICHEM ISE STANDARDS KIT 70011	Sep 06, 1995	Substantially Equivalent	Hichem Diagnostics
K945966	ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS	Feb 10, 1995	Substantially Equivalent	Alko Diagnostic Corp.
K944922	ALKO CAL PACKS FOR CORNING 654 ANALYZERS	Feb 10, 1995	Substantially Equivalent	Alko Diagnostic Corp.
K943012	CALIBRATOR	Nov 28, 1994	Substantially Equivalent	Prisma Systems
K944639	DOCUMENTR AMMONIA/ETHANOLCALIBRATOR	Nov 15, 1994	Substantially Equivalent	Casco Standards
K940760	FLUIDS PACK FOR CORING 238	Sep 06, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K941219	DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR	Aug 09, 1994	Substantially Equivalent	Dupont Medical Products
K942549	ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS	Jul 28, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K940571	SYNERMEDIR CAL I AND SYNERMED IR CAL II	Apr 21, 1994	Substantially Equivalent	Synermed, Inc.
K934607	ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM	Mar 28, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K935543	ACA PLUS FERRITIN CALIBRATOR	Mar 22, 1994	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K933383	REAGENTS FOR HITACHI ISE	Mar 09, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K935547	CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER	Jan 18, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K935018	REAGENTS FOR ORION 1020, AND RELATED ANALYZERS	Jan 18, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K930231	ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS	Jan 13, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K930199	ALKO FLUIDS PACKS FOR NOVA ANALYZERS	Jan 13, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K925464	CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR	Jan 13, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K925385	REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)	Jan 13, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K932623	QUANTIMETRIX BLOOD GLUCOSE CONTROLS	Dec 09, 1993	Substantially Equivalent	Quantimetrix Corp.
K934701	REAGENTS FOR COBAS ISE MODULE	Dec 02, 1993	Substantially Equivalent	Alko Diagnostic Corp.
K934143	N-ASSAY TIA MICROALBUMIN CALIBRATOR SET	Nov 05, 1993	Substantially Equivalent	Crestat Diagnostics, Inc.
K932768	CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323	Oct 18, 1993	Substantially Equivalent	Helena Laboratories
K933955	DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM	Oct 13, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K933693	SIGMA CX-3 CALIBRATION STANDARD LEVEL 2	Oct 13, 1993	Substantially Equivalent	Sigma Chemical Co.
K933702	SIGMA CX-3 CALIBRATION STANDARD LEVEL 1	Oct 08, 1993	Substantially Equivalent	Sigma Chemical Co.
K930104	ACE CLINICAL CHEMISTRY SYSTEM	Aug 23, 1993	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K925101	SYSTEMATE PLUS CALIBRATOR	Feb 23, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K926518	ISE CALIBRATOR FOR DUPONT DIMENSION	Jan 28, 1993	Substantially Equivalent	Alko Diagnostic Corp.
K922043	ROCHE CALIBRATOR SERUM	Jun 16, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K921678	CIBA CORNING ACS FOLATE IMMUNOASSAY	Jun 09, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K915797	CALIBRATOR	Jan 30, 1992	Substantially Equivalent	Alko Diagnostic Corp.
K914909	IL TEST(TM) CALIBRATION SET SP	Jan 22, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K914917	DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR	Dec 13, 1991	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K914750	ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR	Nov 22, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910309	PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION	Mar 29, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904767	ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR	Dec 26, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K903913	PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II	Sep 27, 1990	Substantially Equivalent	Baxter Healthcare Corp
K903888	HI CHEM PROTEIN/LIPIDS LINEARITY	Sep 27, 1990	Substantially Equivalent	Hichem Diagnostics
K902675	MULTI ANALYTE MIXTURE, CALIBRATORS	Jul 31, 1990	Substantially Equivalent	Phoenix Diagnostics, Inc.
K897097	COBAS READY CALIBRATOR KIT	Jun 26, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K897177	CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE	Mar 27, 1990	Substantially Equivalent	Nova Biomedical Corp.
K897071	ROCHE STANDARDS FOR THE COBAS ISE MODULE	Mar 09, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K895717	SODIUM AND POTASSIUM STANDARD	Jan 11, 1990	Substantially Equivalent	Data Medical Associates, Inc.
K895135	HI CHEM CALIBRATOR A+	Oct 23, 1989	Substantially Equivalent	Hichem Diagnostics
K890583	HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2	Mar 13, 1989	Substantially Equivalent	Hichem Diagnostics
K884693	UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS	Dec 15, 1988	Substantially Equivalent	Biomedical Research & Development Laboratories, Inc.
K884227	CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM	Dec 09, 1988	Substantially Equivalent	A-Kem, Inc.
K875285	MULTI-CHEMISTRY LINEARITY STANDARD	Sep 02, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K882258	DC-LIQUICAL CATALOGUE #SE-030	Aug 30, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K882116	TOTAL PROTEIN/ALBUMIN STANDARD	Jun 24, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K881258	PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II	May 27, 1988	Substantially Equivalent	Baxter Healthcare Corp
K875282	QM300 CALIBRATOR B PACK	Feb 17, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K875304	BIOTROL CALIBRANT LEVEL 2	Feb 03, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K875318	BIOTROL CALIBRANT LEVEL 3	Feb 02, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K875288	BIOTROL CALIBRANT LEVEL 1	Feb 02, 1988	Substantially Equivalent	Biotrol, USA, Inc.
K874587	PARAMAX URINE/CSF CALIBRATOR	Jan 05, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874413	REAGENT A AND REAGENT B	Jan 05, 1988	Substantially Equivalent	Seradyn, Inc.
K871755	PROTEIN STANDARD CALIBRATOR	Nov 23, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K873118	BIOTROL REFERENCE	Sep 02, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K873116	MULTI ANALYTE MIXTURES, CALIBRATORS	Sep 02, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K872789	PARAMAX URINE/CSF CALIBRATOR	Sep 02, 1987	Substantially Equivalent	American Dade
K871184	FLAME PHOTOMETER STANDARD #60083 160 NA/8K	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871183	FLAME PHOTOMETER STANDARD #60082 140 NA/5K	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871182	FLAME PHOTOMETER STANDARD #60081 120 NA/2K	May 28, 1987	Substantially Equivalent	In Vitro Diagnostics, Inc.
K871341	QM300 CALIBRATOR A PACK	May 21, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871638	EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95	May 12, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K871664	IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR	May 08, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K864909	DU PONT LIQUID MULTI-ANALYTE CALIBRATOR	Feb 13, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K863502	SOLUTION B- NA 50MEQ/L, K 40 MEQ/L	Oct 21, 1986	Substantially Equivalent	Reagent Laboratory, Inc.
K863489	PARAMAX ELECTROLYTE CALIBRATOR	Sep 29, 1986	Substantially Equivalent	American Dade
K863095	ACE II (TRI-LEVEL)	Sep 26, 1986	Substantially Equivalent	Medical Analysis Systems, Inc.
K862594	SERACON(TM) CAL (PRODUCT NO. DO35)	Aug 19, 1986	Substantially Equivalent	Bhp Diagnostix, Inc.
K862703	EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95	Aug 04, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861786	DU PONT DRUG CALIBRATOR	Jul 29, 1986	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K860765	EMDS CHEMISTRY CALIBRATORS, LEVELS I & II	Apr 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K855014	QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A	Mar 14, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K855199	PARAMAX COMPREHENSIVE CALIBRATOR	Feb 19, 1986	Substantially Equivalent	American Dade
K854092	DMA CALIBRATORS	Oct 25, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K851990	INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU	Jun 25, 1985	Substantially Equivalent	Alpkem Corp.
K851939	CORNING CERTAIN -ISE	Jun 14, 1985	Substantially Equivalent	Corning Medical & Scientific
K851151	FISHER DIAGNOSTICS KDA CALIBRATOR II	May 20, 1985	Substantially Equivalent	Fisher Scientific Co., LLC
K851150	FISHER DIAGNOSTICS KDA CALIBRATOR I	May 20, 1985	Substantially Equivalent	Fisher Scientific Co., LLC
K850859	COBAS CALIBRATOR SERUM	May 10, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K850405	CALIBRATOR B 88133	Apr 01, 1985	Substantially Equivalent	Hi Chem, Inc.
K850396	ROCHE STANDARDS FOR CHLORIDE & CO2	Feb 27, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K844709	CRITIC-ARS	Jan 08, 1985	Substantially Equivalent	Dimension Diagnostics
K844344	GEMCAL ENI REFERENCE SERUM	Jan 03, 1985	Substantially Equivalent	Biocell Laboratories, Inc.
K844585	REFERRIL CALIBRATORS	Dec 11, 1984	Substantially Equivalent	Instrumentation Laboratory CO
K844027	SERACON TM SR III	Nov 27, 1984	Substantially Equivalent	Bhp Diagnostix, Inc.
K844026	SERACON TM SR IV	Nov 27, 1984	Substantially Equivalent	Bhp Diagnostix, Inc.
K843947	DOUMENT TM LINEARITY TEST STANDARDS	Oct 17, 1984	Substantially Equivalent	Casco Standards
K841464	CHANGES IN THE CHEMICAL COMP. OF 5	Jun 22, 1984	Substantially Equivalent	Nova Biomedical Corp.
K841456	VENTREXYME EIA CONTROLS IMMUNOASSAY	May 21, 1984	Substantially Equivalent	Vxr, Inc.
K841420	SODIUM & POTASSIUM STANDARD SOL 80	May 11, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K841419	SODIUM & POTASSIUM STANDARD SOLUT	May 11, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K840278	HDL CHOLESTEROL CONTROLS-LEVELS	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K840219	TRIGLYCERIDE/CHOLESTEROL AQUEOUS	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K833005	PARAMAX BILIRUBIN CALIBRATORS	Nov 14, 1983	Substantially Equivalent	American Dade
K832695	LYPHOCHEK SERUM REF. STANDARD-BOVINE	Oct 04, 1983	Substantially Equivalent	Bio-Rad
K832046	SERALYZER MULTICOMPONENT CALIBRATORS	Aug 11, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K831030	COBAS STANDARDS FOR GLUCOSE & BUN	May 09, 1983	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K830341	SALT BRIDGE SOLUTION & URINE DILUENT	Mar 10, 1983	Substantially Equivalent	Shaban Mfg. Co.
K823044	KM-KAL L3	Dec 09, 1982	Substantially Equivalent	Kmn Products, Inc.
K823046	KM-KAL L5	Nov 05, 1982	Substantially Equivalent	Kmn Products, Inc.
K823045	KM-KAL L4	Nov 05, 1982	Substantially Equivalent	Kmn Products, Inc.
K823043	KM-KAL L2	Nov 05, 1982	Substantially Equivalent	Kmn Products, Inc.
K823042	KM-KAL L1	Nov 05, 1982	Substantially Equivalent	Kmn Products, Inc.
K822937	GLUCOSE/UREA NITROGEN STANDARD	Nov 05, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822289	CO2/CI STANDARDS	Aug 24, 1982	Substantially Equivalent	Gilford Diagnostics
K821885	REF. ELECTRODE SOL'N.;STANDARD B	Jul 13, 1982	Substantially Equivalent	Avl Scientific Corp.
K821794	NOVA V FLUIDS PACK & EXTERNAL STANDARDS	Jul 02, 1982	Substantially Equivalent	Shaban Mfg. Co.
K821623	NOVA IV FLUIDS PACK & EXTERNAL STANDARDS	Jun 14, 1982	Substantially Equivalent	Shaban Mfg. Co.
K821030	NOVA II FLUIDS PACK	May 03, 1982	Substantially Equivalent	Shaban Mfg. Co.
K820947	NOVA III FLUIDS PACK	Apr 26, 1982	Substantially Equivalent	Shaban Mfg. Co.
K820701	NOVA I FLUIDS PACK	Apr 01, 1982	Substantially Equivalent	Shaban Mfg. Co.
K820700	EXTERNAL STANDARDS-SODIUMNPOTASSIUM	Apr 01, 1982	Substantially Equivalent	Shaban Mfg. Co.
K813127	SODIUM & POTASSIUM PRODUCTS	Jan 22, 1982	Substantially Equivalent	Alko Diagnostic Corp.
K813411	DOCUMENT LINEARITY TEST STANDARDS	Dec 18, 1981	Substantially Equivalent	North American Standards
K812649	BECKMAN ICS CALIBRATOR	Oct 19, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K811921	HITACHI 705 CALIBRATOR	Jul 23, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K810964	BIO SET TM PHOSPHOROUS CALIBRATOR	Apr 17, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K803051	FLAME PHOTOMETRY REAGENTS	Jan 09, 1981	Substantially Equivalent	Laboratory Products, Inc.
K802825	COMBINED GLUCOSE AND BUN STANDARDS	Dec 11, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K802824	COMBUNED CALCIUM AND PHOSPHORUS STD.	Dec 11, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K802633	BUN/GLUCOSE STANDARDS	Dec 11, 1980	Substantially Equivalent	Gilford Diagnostics
K802632	ALBUMIN/TOTAL PROTEIN STANDARDS	Dec 11, 1980	Substantially Equivalent	Gilford Diagnostics
K802741	CENTRIFICHEM COMB. SERUM-BASED CALIB.	Dec 10, 1980	Substantially Equivalent	Union Carbide Corp.
K801222	REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER	Jun 26, 1980	Substantially Equivalent	Simmler, Inc.
K800910	GAL-PUT CONTROLS, NORMAL&DEFICIENT	Apr 29, 1980	Substantially Equivalent	Sigma Chemical Co.
K800043	CESIUM DILUENT (1.5 MM/L)	Jan 21, 1980	Substantially Equivalent	Gilford Diagnostics
K800041	SODIUM/POTASSIUM 140/5 MEQ/L)	Jan 21, 1980	Substantially Equivalent	Gilford Diagnostics
K800040	SODIUM/POTASSIUM (100/100 MEQ/E)	Jan 21, 1980	Substantially Equivalent	Gilford Diagnostics
K792487	SERACON-SRII	Dec 31, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K792486	SERACON-SRI (PROD. # D029	Dec 31, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K792485	SERACON-SRI	Dec 31, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K792384	PRINCIPAL ANALYTE REFERENCE SERUM	Dec 06, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K792013	LANCER L-INA HUMAN REFERENCE SERUM	Nov 13, 1979	Substantially Equivalent	Sherwood Medical Industries
K791874	CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD	Oct 17, 1979	Substantially Equivalent	Gilford Diagnostics
K791956	SERACON CAL D025	Oct 11, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K791694	CALIBRATOR II	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K791693	CALIBRATOR I	Sep 17, 1979	Substantially Equivalent	Hi Chem, Inc.
K782039	SERACON-N	Feb 26, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K782037	SERACON-A	Feb 08, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K781758	SERACON-SRII	Dec 04, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K781757	SERACON-SRI	Dec 04, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K781702	CALIBRATOR, BOVINE SERUM	Nov 15, 1978	Substantially Equivalent	Bio-Reagents & Diagnostics, Inc.
K780553	COMP. CLIN. CHEM. REF. SERUM-BENCHMARK	May 19, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K770012	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C	Apr 18, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K770011	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B	Apr 18, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K770010	Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A	Apr 18, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K770494	BLOOD GAS ANALYZER-CALIBRATION GAS	Apr 15, 1977	Substantially Equivalent	Gardner Cryogenics
K770142	SMA REFERENCE SERUM 3	Feb 11, 1977	Substantially Equivalent	Technicon Instruments Corp.
K761309	OB-GYN CONTROL SERA (CODE 196300)	Dec 30, 1976	Substantially Equivalent	Amersham Corp.