Product Code: JJX FDA class 1 21 CFR 862.1660

Single (Specified) Analyte Controls (Assayed And Unassayed)

Clinical Chemistry

This device consists of assayed and unassayed single-analyte controls used in clinical chemistry laboratories to verify the accuracy and precision of systems measuring a specific individual biochemical analyte, supporting quality control practices across routine and specialty testing. It is classified as FDA Class 1 and requires only general controls with no premarket notification. The product code is JJX, regulated under 21 CFR 862.1660, within the Clinical Chemistry medical specialty.

View on FDA

510(k)s

493

FEI Numbers

269

Registration Numbers

269

Unique Applicants

145

Years Active

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Basic Information

Product Code: JJX
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 493 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170678	Beta-CrossLaps CalCheck 5	Apr 04, 2017	Substantially Equivalent	Roche Diagnostics
K162173	Elecsys CYFRA 21-1 CalCheck 5	Jan 12, 2017	Substantially Equivalent	Roche Diagnostics
K162514	Multichem A1c	Oct 26, 2016	Substantially Equivalent	Technopath Manufacturing
K161874	Audit MicroControls Linearity DROP LQ Blood Glucose	Aug 10, 2016	Substantially Equivalent	Aalto Scientific, Ltd.
K161526	LIAISON CMV IgM Serum Control Set	Jun 30, 2016	Substantially Equivalent	DiaSorin, Inc.
K161522	LIAISON EBV IgM Serum Control Set	Jun 30, 2016	Substantially Equivalent	DiaSorin, Inc.
K161082	IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers	May 17, 2016	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K152117	Dropper hsCRP High Sensitivity CRP Control	Apr 21, 2016	Substantially Equivalent	Quantimetrix Corporation
K151742	Contour Next Control Solution	Sep 23, 2015	Substantially Equivalent	Bayer Healthcare
K143687	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	Jul 17, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K150955	Elecsys Progesterone III Cal Check 5	May 01, 2015	Substantially Equivalent	Roche Diagnostics
K150132	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	Apr 13, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics
K143324	IDS-iSYS CTX-I Calibration Verifiers	Mar 30, 2015	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K143373	IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material	Feb 26, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143636	IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material	Feb 25, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143680	ADVIA Centaur IgE Master Curve Material	Jan 27, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143639	IMMULITE 2000 CEA Calibration Verification Material	Jan 23, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics
K143571	Audit MicroControls Linearity LQ Cystatin-C	Jan 23, 2015	Substantially Equivalent	Aalto Scientific, Ltd.
K143504	IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material	Jan 14, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material	Dec 24, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143376	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	Dec 23, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143296	AIA-PACK C-Peptide Control Set	Dec 16, 2014	Substantially Equivalent	Tosoh Bioscience, Inc.
K143284	Elecsys Estradiol III Calcheck	Dec 16, 2014	Substantially Equivalent	Roche Diagnostics
K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)	Dec 05, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity	Nov 21, 2014	Substantially Equivalent	Aalto Scientific, Ltd.
K142878	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material	Oct 30, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K142864	ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)	Oct 29, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K142811	IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)	Oct 29, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K142127	ELECSYS ESTRADIOL III CALCHECK 5	Sep 05, 2014	Substantially Equivalent	Roche Diagnostics
K141772	IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL	Aug 19, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K141444	IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL	Jul 09, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133816	IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL	Jun 24, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140818	IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C	May 01, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140541	IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C	Apr 01, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140505	ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL	Mar 31, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140534	ELECSYS PRECICONTROL TS	Mar 27, 2014	Substantially Equivalent	Roche Diagnostics
K140267	ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)	Mar 10, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140258	IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL	Mar 05, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133550	VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT	Feb 05, 2014	Substantially Equivalent	Maine Standards Company, LLC
K133197	FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE	Jan 17, 2014	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K132739	IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL	Jan 14, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133284	ELECSYS CK-MB CALCHECK 5	Nov 22, 2013	Substantially Equivalent	Roche Diagnostics
K133122	IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)	Oct 30, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133124	IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA	Oct 25, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K133003	RIGHTEST CONTROL SOLUTION	Oct 24, 2013	Substantially Equivalent	Bionime Corporation
K133128	IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION	Oct 22, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K131662	IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL	Oct 10, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K132391	IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL	Sep 20, 2013	Substantially Equivalent	Siemens Helathcare Diagnostics, Inc.
K131536	IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL	Aug 12, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K131999	HBA1C CONTROL, LEVEL 1 AND LEVEL 2	Jul 26, 2013	Substantially Equivalent	Randox Laboratories, Ltd.
K131776	ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3	Jul 18, 2013	Substantially Equivalent	Randox Laboratories, Ltd.
K123127	VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406	Jun 14, 2013	Substantially Equivalent	Maine Standards Co.
K131136	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	May 31, 2013	Substantially Equivalent	Bionostics, Inc.
K130764	AUDIT MICROCV VITAMIN D LINEARITY SET	Apr 26, 2013	Substantially Equivalent	Aalto Scientific, Ltd.
K130157	AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET	Mar 19, 2013	Substantially Equivalent	Aalto Scientific, Ltd.
K122534	IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL	Mar 14, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K123851	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	Feb 14, 2013	Substantially Equivalent	Bionostics, Inc.
K123966	GLUCOSE METER-CHECK SOLUTION FOR BAYER	Jan 25, 2013	Substantially Equivalent	Bionostics, Inc.
K123612	FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA	Jan 17, 2013	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K123798	LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK	Jan 09, 2013	Substantially Equivalent	Bio-Rad Laboratories
K122242	ELECSYS CA 15-3 II CALCHECK 5	Dec 05, 2012	Substantially Equivalent	Roche Diagnostics
K121895	ELECSYS HSV-2 IGG IMMUNOASSAY	Aug 24, 2012	Substantially Equivalent	Roche Diagnostics
K122141	IDS-ISYS IGF-I CALIBRATION VERIFIERS	Aug 07, 2012	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K121746	RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)	Jul 11, 2012	Substantially Equivalent	Randox Laboratories, Ltd.
K121588	RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3	Jun 20, 2012	Substantially Equivalent	Randox Laboratories, Ltd.
K121534	CONE-TROL HEMOGLOBIN A1C CONTROL SET	Jun 20, 2012	Substantially Equivalent	Cone Bioproducts
K121237	BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE	May 18, 2012	Substantially Equivalent	Cliniqa Corporation
K121279	ELECSYS LH CALCHECK 5	May 10, 2012	Substantially Equivalent	Roche Diagnostics
K113177	COMPLETE D 25-OH VITAMIN D CONTROL	May 10, 2012	Substantially Equivalent	Quantimetrix Corp.
K121084	LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L	May 09, 2012	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K112653	ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS	Apr 09, 2012	Substantially Equivalent	ACON Laboratories, Inc.
K111938	IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...	Feb 14, 2012	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K112143	AUDIT MICROCV T-UPTAKE LINEARITY	Jan 31, 2012	Substantially Equivalent	Aalto Scientific, Ltd.
K113764	GLUCOSE METER-CHECK SOLUTION FOR INFOPIA	Jan 30, 2012	Substantially Equivalent	Bionostics, Inc.
K113524	VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT	Jan 27, 2012	Substantially Equivalent	Maine Standards Co.
K112352	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	Dec 23, 2011	Substantially Equivalent	Bionostics, Inc.
K112603	ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS	Nov 04, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K112528	ELECSYS T4 CALCHECK 5	Oct 18, 2011	Substantially Equivalent	Roche Diagnostics Corporation
K110061	CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL	Sep 21, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K112356	GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE	Sep 19, 2011	Substantially Equivalent	Bionostics, Inc.
K112113	ELECSYS MYOGLOBIN CALCHECK 5	Sep 14, 2011	Substantially Equivalent	Roche Diagnostics
K111650	IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...	Sep 06, 2011	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K112104	ELECSYS N-MID OSTEOCALCIN CALCHECK 5	Aug 25, 2011	Substantially Equivalent	Roche Diagnostics
K111552	ELECSYS T3 CALCHECK 5	Jul 21, 2011	Substantially Equivalent	Roche Diagnostics
K111349	ELECSYS SHBG CALCHECK 5	Jun 09, 2011	Substantially Equivalent	Roche Diagnostics
K110641	FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL	May 27, 2011	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K110613	ELECSYS PROLACTIN II CALCHECK 5	May 12, 2011	Substantially Equivalent	Roche Diagnostics
K103744	DROPPER A1C DIABETES CONTROL	May 12, 2011	Substantially Equivalent	Quantimetrix Corp.
K103683	IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)	Apr 28, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K110436	FDI GLUCOSE CONTROL SOLUTION FOR AVIVA	Apr 20, 2011	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K110412	IDS-ISYS IFG-I CONTROL SET	Mar 16, 2011	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K103553	LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION	Feb 10, 2011	Substantially Equivalent	Bionostics, Inc.
K103450	FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE	Jan 25, 2011	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K103402	ELECSYS DHEA-S CALCHECK 5	Jan 07, 2011	Substantially Equivalent	Roche Diagnostics
K101427	AUDIT MICROCV HS-CRP LINEARITY SET	Dec 23, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K100715	AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5	Dec 23, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K103099	PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH	Dec 06, 2010	Substantially Equivalent	Roche Diagnostics
K102904	ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL	Nov 23, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K103162	ELECSYS PTH CALCHECK 5	Nov 18, 2010	Substantially Equivalent	Roche Diagnostics
K102086	ELECSYS CA 125 II CALCHECK 5	Nov 01, 2010	Substantially Equivalent	Roche Diagnostics
K102269	ELECSYS IGE CALCHECK 5	Oct 07, 2010	Substantially Equivalent	Roche Diagnostics
K101856	ELECSYS CEA CALCHECK 5	Oct 05, 2010	Substantially Equivalent	Roche Diagnostics
K101365	ELECSYS CA 19-9 CALCHECK 5	Oct 05, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K102260	FDI GLUCOSE CONTROL SOLUTIONS	Sep 24, 2010	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K102267	ELECSYS FERRITIN CALCHECK 5	Sep 10, 2010	Substantially Equivalent	Roche Diagnostics
K102044	ELECSYS DIGOXIN CALCHECK 5	Aug 31, 2010	Substantially Equivalent	Roche Diagnostics
K093724	FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION	Jul 29, 2010	Substantially Equivalent	Taidoc Technology Corporation
K101075	ELECSYS INSULIN CALCHECK 5	Jun 11, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K100750	AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5	May 21, 2010	Substantially Equivalent	Aalto Scientific, Ltd.
K094031	ELECSYS FOLATE III CALCHECK 5	Apr 27, 2010	Substantially Equivalent	Roche Diagnostics
K100810	ELECSYS C-PEPTIDE CALCHECK 5	Apr 26, 2010	Substantially Equivalent	Roche Diagnostics
K092911	SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER	Apr 26, 2010	Substantially Equivalent	Diazyme Laboratories
K093836	ELECSYS TSH CALCHECK 5	Apr 15, 2010	Substantially Equivalent	Roche Diagnostics
K100747	CONTREX PLUS LOW CONTROL SOLUTION	Apr 14, 2010	Substantially Equivalent	Apex BioTechnology Corp.
K100594	ELECSYS TROPONIN I CALCHECK 5	Apr 01, 2010	Substantially Equivalent	Roche Diagnostics
K093582	ELECSYS CK-MB CALCHECK 5	Mar 29, 2010	Substantially Equivalent	Roche Diagnostics
K092848	ELECSYS TROPONIN T CALCHECK 5	Mar 19, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K093700	ELECSYS HCG STAT CALCHECK 5	Mar 04, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K092169	ELECSYS PROBNP II CALCHECK 5	Dec 16, 2009	Substantially Equivalent	Roche Diagnostics
K093498	LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913	Dec 14, 2009	Substantially Equivalent	DiaSorin, Inc.
K092749	MAS AND MINI-TROL PTH CONTROL	Dec 03, 2009	Substantially Equivalent	Microgenics Corporation
K092993	ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL	Nov 20, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K092168	ELECSYS HCG+B CALCHECK 5	Nov 16, 2009	Substantially Equivalent	Roche Diagnostics
K092888	ELECSYS TOXO IGG CALCHECK 5	Nov 10, 2009	Substantially Equivalent	Roche Diagnostics Corp.
K091914	OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION	Nov 06, 2009	Substantially Equivalent	Bionostics, Inc.
K092585	ELECSYS RUBELLA IGGA CALCHECK 5	Oct 30, 2009	Substantially Equivalent	Roche Diagnostics
K091601	ELECYS ANTI-CCP CALCHECK	Sep 25, 2009	Substantially Equivalent	Roche Diagnostics Corp.
K090104	LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603	Sep 09, 2009	Substantially Equivalent	DiaSorin, Inc.
K092645	FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3	Sep 05, 2009	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K091123	ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS	Aug 14, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K091460	ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087	Aug 06, 2009	Substantially Equivalent	American Biological Technologies, Inc.
K090943	ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089	May 27, 2009	Substantially Equivalent	American Biological Technologies, Inc.
K090311	ELECSYS RUBELLA IGG CALCHECK	May 05, 2009	Substantially Equivalent	Roche Diagnostics
K090854	ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090	Apr 16, 2009	Substantially Equivalent	American Biological Technologies, Inc.
K083655	ELECSYS TOXO IGG CALCHECK	Feb 12, 2009	Substantially Equivalent	Roche Diagnostics
K083549	ABT GLUCOSE CONTROL SOLUTION	Dec 22, 2008	Substantially Equivalent	American Biological Technologies, Inc.
K081478	RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS	Oct 06, 2008	Substantially Equivalent	Bionostics, Inc.
K082395	GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002	Sep 18, 2008	Substantially Equivalent	Bionostics, Inc.
K080643	ELECSYS ANTI-TSHR CALCHECK	Aug 22, 2008	Substantially Equivalent	Roche Diagnostics
K081915	FDTX GLUCOSE CONTROL SOLUTION	Aug 08, 2008	Substantially Equivalent	Fujirebio Diagnostics Texas, Inc.
K080273	AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION	Aug 08, 2008	Substantially Equivalent	Fujirebio Diagnostics Texas, Inc.
K081403	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK	Jul 25, 2008	Substantially Equivalent	Bionostics, Inc.
K080147	ELECSYS PROBNP II CALCHECK	Feb 27, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K071648	EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS	Aug 22, 2007	Substantially Equivalent	Canterbury Scientific , Ltd.
K071587	ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY	Jul 30, 2007	Substantially Equivalent	Inverness Medical Innovations, Inc.
K070506	SMS MULTI GLUCOSE CONTROL, MODEL 2120049	Apr 18, 2007	Substantially Equivalent	Medical Specialties Supply Co., Inc.
K070649	SMS GLUCOSE CONTROL, MODEL 2120061	Apr 12, 2007	Substantially Equivalent	Spectrum Medical Supply, Inc.
K062957	FASTPACK TOTAL PSA METHOD VERIFICATION KIT	Apr 02, 2007	Substantially Equivalent	Qualigen, Inc.
K063855	LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047	Feb 01, 2007	Substantially Equivalent	Liberty Healthcare Group, Inc.
K062972	PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS	Oct 13, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K062501	VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901	Sep 29, 2006	Substantially Equivalent	Maine Standards Co.
K060510	DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT	Jun 19, 2006	Substantially Equivalent	Drew Scientific , Ltd.
K060706	LIBERTY NORMAL GLUCOSE CONTROL SOLUTION	Apr 28, 2006	Substantially Equivalent	Liberty Healthcare Group, Inc.
K060570	HEMOGLOBIN ALC CONTROL	Apr 13, 2006	Substantially Equivalent	Compass Bioscience
K060215	ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002	Mar 24, 2006	Substantially Equivalent	Eurotrol B.V.
K060481	LIBERTY GLUCOSE CONTROL SOLUTION	Mar 09, 2006	Substantially Equivalent	Liberty Healthcare Group, Inc.
K060426	LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041	Mar 09, 2006	Substantially Equivalent	Liberty Healthcare Group, Inc.
K060133	ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET	Feb 16, 2006	Substantially Equivalent	Inverness Medical Innovations, Inc.
K060027	ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)	Jan 26, 2006	Substantially Equivalent	Biokit, S.A.
K053327	OXICOM CONTROL	Jan 26, 2006	Substantially Equivalent	Bionostics, Inc.
K052980	LIBERTY GLUCOSE CONTROL, MODEL 2120031	Nov 30, 2005	Substantially Equivalent	Liberty Healthcare Group, Inc.
K053059	ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK	Nov 28, 2005	Substantially Equivalent	Roche Diagnostics
K052679	CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E	Nov 18, 2005	Substantially Equivalent	Cliniqa Corporation
K052010	HBA1C LINEARITY SET	Oct 04, 2005	Substantially Equivalent	Cone Bioproducts
K050983	IRMA TRUPOINT CREATININE CONTROL KIT	May 16, 2005	Substantially Equivalent	International Technidyne Corporation
K050961	RNA1C CONTROL FOR NYCOCARD HBA1C	May 13, 2005	Substantially Equivalent	Bionostics, Inc.
K050328	PREGNANCY-SKREEN	Mar 29, 2005	Substantially Equivalent	Biochemical Diagnostic, Inc.
K050100	RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER	Feb 25, 2005	Substantially Equivalent	Bionostics, Inc.
K043584	LIQUICHEK BNP CONTROL	Feb 08, 2005	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K043320	MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II	Dec 17, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K043070	LIQUID STABLE HBA1C CONTROL	Dec 09, 2004	Substantially Equivalent	Canterbury Scientific , Ltd.
K042717	MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL	Nov 05, 2004	Substantially Equivalent	Medical Analysis Systems, Inc.
K042837	LIQUICHEK ELEVATED CRP CONTROL	Nov 02, 2004	Substantially Equivalent	Bio-Rad
K042448	DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT	Oct 29, 2004	Substantially Equivalent	General Atomics
K042303	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	Sep 27, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics
K042080	TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM	Aug 19, 2004	Substantially Equivalent	Home Diagnostics, Inc.
K041687	ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR	Aug 18, 2004	Substantially Equivalent	Abbott Laboratories
K041898	CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM	Aug 16, 2004	Substantially Equivalent	Cliniqa Corporation
K041871	INTERLAB MICROCAL SERUM CONTROLS	Aug 16, 2004	Substantially Equivalent	Trouble Shooter Consuling, Inc.
K041194	ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H	Aug 16, 2004	Substantially Equivalent	Medical Analysis Systems, Inc.
K040927	LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS	May 17, 2004	Substantially Equivalent	Cliniqa Corporation
K040918	WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2	May 17, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K041016	NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS	May 07, 2004	Substantially Equivalent	Nova Biomedical Corp.
K040351	RANDOX LIQUID CRP CONTROLS	Mar 12, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K034048	R&D GLU-LINE HEMATOLOGY CONTROL	Mar 10, 2004	Substantially Equivalent	R&D Systems, Inc.
K040455	LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS	Mar 05, 2004	Substantially Equivalent	Cliniqa Corporation
K040025	A1C-CELLULAR	Mar 02, 2004	Substantially Equivalent	Streck Laboratories, Inc.
K040157	ELECSYS C-PEPTIDE CALCHECK	Feb 25, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K030849	AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1	Feb 02, 2004	Substantially Equivalent	N-Dia, Inc.
K033433	NOVA GLUCOSE CONTROL SOLUTIONS	Jan 02, 2004	Substantially Equivalent	Nova Biomedical Corp.
K033127	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS	Oct 31, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics
K032993	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS	Oct 31, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K032819	GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM	Oct 20, 2003	Substantially Equivalent	Bionostics, Inc.
K031873	I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET	Oct 07, 2003	Substantially Equivalent	I-Stat Corporation
K031990	ELECSYS PRECICONTROL TROPONIN T	Aug 20, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031698	ELECYS SHBG CALCHECK	Aug 20, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031890	MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL	Jul 16, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K030628	SAS RSV CONTROL KIT	Mar 17, 2003	Substantially Equivalent	Sa Scientific, Inc.
K030065	WAKO NEFA LINEARITY SET	Feb 11, 2003	Substantially Equivalent	Wako Chemicals USA, Inc.
K020883	ELECSYS PROBNP CALCHECK	Nov 29, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K022769	LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION	Nov 13, 2002	Substantially Equivalent	Bionostics, Inc.
K023307	MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL	Oct 31, 2002	Substantially Equivalent	Medical Analysis Systems, Inc.
K022725	CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013	Sep 23, 2002	Substantially Equivalent	Good Biotech Corp.
K022758	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER	Sep 17, 2002	Substantially Equivalent	Cliniqa Corporation
K022491	LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS	Aug 27, 2002	Substantially Equivalent	Cliniqa Corporation
K022232	CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3	Aug 01, 2002	Substantially Equivalent	Cliniqa Corporation
K021697	GLUCOSE CONTROL SOLUTION FOR BD LATITUDE	Jul 12, 2002	Substantially Equivalent	Bionostics, Inc.
K021624	RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4	Jul 12, 2002	Substantially Equivalent	Bionostics, Inc.
K020217	ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY	Mar 15, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K020369	ELECSYS ANTI-TG CALCHECK	Mar 06, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K013900	VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS	Dec 21, 2001	Substantially Equivalent	Ortho-Clinical Diagnostics
K013119	VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006	Nov 16, 2001	Substantially Equivalent	Maine Standards Co.
K013147	GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE	Oct 24, 2001	Substantially Equivalent	Bionostics, Inc.
K013130	N LP(A) CONTROL SY	Oct 18, 2001	Substantially Equivalent	Dade Behring, Inc.
K012561	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS	Aug 29, 2001	Substantially Equivalent	Ortho-Clinical Diagnostics
K012430	MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3	Aug 27, 2001	Substantially Equivalent	Bionostics, Inc.
K012122	VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005	Aug 20, 2001	Substantially Equivalent	Maine Standards Co.
K011463	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS	Jun 13, 2001	Substantially Equivalent	Ortho-Clinical Diagnostics
K011250	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	Jun 13, 2001	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K010693	VIGIL DNASE B CONTROL	Apr 11, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010428	ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349	Mar 13, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010237	ELECSYS HCG+B CALCHECK	Feb 14, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003967	CA 125 II CALCHECK	Jan 12, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003772	ELECSYS DHEA-S CALCHECK	Dec 20, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K003095	FASTPACK CONTROL	Nov 29, 2000	Substantially Equivalent	Qualigen, Inc.
K001651	BIO-RAD %CDT TIA	Nov 22, 2000	Substantially Equivalent	Axis-Shield Biochemicals, Asa
K003112	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS	Nov 02, 2000	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K002540	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS	Sep 18, 2000	Substantially Equivalent	Bionostics, Inc.
K001443	SUGAR CHEX ONE	Jun 29, 2000	Substantially Equivalent	Streck Laboratories, Inc.
K001846	ELECSYS INSULIN CALCHECK	Jun 28, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001458	SYNCHRON CONTROL	Jun 02, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K001014	ELECSYS ANTI-TPO CALCHECK	Jun 01, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001015	ELECSYS THYROGLOBULIN CALCHECK	Apr 27, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K992781	ARCHITECH AFP MASTERCHECK, MODEL 6C01-05	Apr 05, 2000	Substantially Equivalent	Bio-Rad
K000042	ELECSYS B-CROSSLAPS CALCHECK	Mar 17, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K000231	TRIAGE BNP CALIBRATION VERIFICATION CONTROLS	Mar 02, 2000	Substantially Equivalent	Biosite Incorporated
K000230	TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS	Feb 29, 2000	Substantially Equivalent	Biosite Incorporated
K000318	BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM	Feb 28, 2000	Substantially Equivalent	Bionostics, Inc.
K000056	BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS	Feb 24, 2000	Substantially Equivalent	Biocell Laboratories, Inc.
K994200	ACCESS HYBRITECH PSA QC, MODEL 37209	Jan 18, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994277	ACCESS OSTASE QC	Jan 14, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993210	ACCESS HYBRITECH FREE PSA QC, MODEL 37219	Jan 05, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993642	ELECSYS PARATHYROID HORMONE CALCHECK	Nov 30, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K981914	TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION	Nov 26, 1999	Substantially Equivalent	The Binding Site, Ltd.
K991075	ATLAST GLUCOSE CONTROL SOLUTION	May 10, 1999	Substantially Equivalent	Amira Medical, Inc.
K990984	VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS	Apr 08, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K990608	ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05	Mar 30, 1999	Substantially Equivalent	Bio-Rad
K990783	VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS	Mar 25, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K990393	ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05	Mar 22, 1999	Substantially Equivalent	Bio-Rad
K990755	SAS HCG URINE CONTROLS	Mar 19, 1999	Substantially Equivalent	Sa Scientific, Inc.
K990720	SAS HCG SERUM CONTROLS	Mar 19, 1999	Substantially Equivalent	Sa Scientific, Inc.
K984625	ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05	Feb 02, 1999	Substantially Equivalent	Bio-Rad
K984604	ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05	Feb 02, 1999	Substantially Equivalent	Bio-Rad
K990026	VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS	Jan 29, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K984626	ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5	Jan 29, 1999	Substantially Equivalent	Bio-Rad
K990162	ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01	Jan 28, 1999	Substantially Equivalent	Bio-Rad
K990061	VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS	Jan 25, 1999	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K984327	ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K984319	ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05	Dec 22, 1998	Substantially Equivalent	Bio-Rad
K983432	SUPREME II CONTROL SOLUTIONS	Dec 17, 1998	Substantially Equivalent	Chronimed, Inc.
K984324	ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05	Dec 15, 1998	Substantially Equivalent	Bio-Rad
K984323	ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05	Dec 15, 1998	Substantially Equivalent	Bio-Rad
K984318	ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05	Dec 15, 1998	Substantially Equivalent	Bio-Rad
K984011	VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS	Dec 07, 1998	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K984071	LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644	Dec 03, 1998	Substantially Equivalent	Bio-Rad
K984073	ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05	Nov 25, 1998	Substantially Equivalent	Bio-Rad
K984070	ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05	Nov 25, 1998	Substantially Equivalent	Bio-Rad
K984072	ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05	Nov 24, 1998	Substantially Equivalent	Bio-Rad
K983971	CARDIAC MARKER CONTROL MODULE, MODEL CCCM	Nov 18, 1998	Substantially Equivalent	Diagnostic Products Corp.
K983578	ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05	Nov 12, 1998	Substantially Equivalent	Bio-Rad
K982471	B2-MICROGLOBULIN CONTROL SET SERUM	Aug 06, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K982591	DADE TRU-LIQUID CARDIAC CONTROL	Aug 05, 1998	Substantially Equivalent	Dade Behring, Inc.
K982022	VIGIL HEMOGLOBIN (HBALC) CONTROLS	Jul 06, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K981864	ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219	Jun 12, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K981622	DADE TRU-LIQUID CARDIAC CONTROL	Jun 08, 1998	Substantially Equivalent	Dade Behring, Inc.
K981281	ELECSYS CALCHECK FERRITIN	Apr 24, 1998	Substantially Equivalent	Roche Diagnostics GmbH
K981278	ELECSYS CALCHECK CA 125II	Apr 23, 1998	Substantially Equivalent	Roche Diagnostics GmbH
K974811	ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL	Feb 10, 1998	Substantially Equivalent	Boston Biomedica, Inc.
K974644	VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS	Jan 13, 1998	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K974609	REP CHOLESTEROL PROFILE CONTROL-II	Jan 06, 1998	Substantially Equivalent	Helena Laboratories
K973676	PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH	Dec 16, 1997	Substantially Equivalent	Sorrento Biochemical, Inc.
K973678	ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH	Dec 15, 1997	Substantially Equivalent	Sorrento Biochemical, Inc.
K973677	DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH	Dec 15, 1997	Substantially Equivalent	Sorrento Biochemical, Inc.
K974383	ELECSYS CALCHECK VITAMIN B12	Dec 08, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K974108	SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)	Nov 26, 1997	Substantially Equivalent	Quidel Corp.
K973832	OPUS HLH CONTROLS	Oct 27, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K973358	MYOGLOBIN CONTROL SET	Oct 06, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K973099	PROSTATE SPECIFIC ANTIGEN CONTROL	Sep 29, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K973072	WAKO NEFA LINEARITY SET	Sep 12, 1997	Substantially Equivalent	Wako Chemicals USA, Inc.
K972721	ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P	Aug 06, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K972687	CARDIAC STATUS CONTROLS/TROPONIN I	Jul 28, 1997	Substantially Equivalent	Spectral Diagnostics, Inc.
K972287	DADE TRU-LIQUID BILIRUBIN CONTROL	Jul 07, 1997	Substantially Equivalent	Dade Intl., Inc.
K971014	LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS	Apr 23, 1997	Substantially Equivalent	Lifescan, Inc.
K970778	LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4	Apr 17, 1997	Substantially Equivalent	More Diagnostics
K971051	IMMULITE THYROID AUTOANTIBODY CONTROL MODULE	Apr 10, 1997	Substantially Equivalent	Diagnostic Products Corp.
K970984	THE ELECSYS CALCHECK PROGESTERONE	Apr 02, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970459	ELECSYS CALCHECK CEA	Mar 06, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970458	ELECSYS CALCHECK PSA	Mar 06, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970452	ELECSYS CALCHECK CEA	Mar 06, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970527	ABBOTT HCG SERUM CONTROLS	Mar 03, 1997	Substantially Equivalent	Abbott Laboratories
K970148	ELECSYS CALCHECK ESTRADIOL	Feb 10, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970176	HCG CONTROLS	Feb 06, 1997	Substantially Equivalent	International Newtech Development, Inc.
K970146	ELECSYS CALCHECK TESTOSTERONE	Jan 30, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K964830	ELECSYS CALCHECK LH	Dec 16, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K964278	WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6	Nov 22, 1996	Substantially Equivalent	Clinical Controls, Inc.
K963909	HEMOCUE GLUCOLIN	Nov 08, 1996	Substantially Equivalent	Direct Solutions
K964053	HEMOCUE GLUCOTROL	Nov 01, 1996	Substantially Equivalent	Direct Solutions
K961432	RADIAS GALT TEST	Oct 28, 1996	Substantially Equivalent	Bio-Rad
K963551	BIO-CSF LIQUID CONTROL LEVEL 1 AND 2	Oct 07, 1996	Substantially Equivalent	Biocell Laboratories, Inc.
K963181	ELECSYS CALCHECK T UPDATE	Sep 10, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963165	ELECSYS CALCHECK HCG	Aug 30, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963240	IMMULITE ACTH CONTROL MODULE (LACCM)	Aug 29, 1996	Substantially Equivalent	Diagnostic Products Corp.
K962975	PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)	Aug 29, 1996	Substantially Equivalent	Diagnostic Products Corp.
K963178	ELECSYS CALCHECK T4	Aug 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963167	ELECYS CALCHECK T 3	Aug 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963164	ELECSYS CALCHECK FT4	Aug 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963163	ELECSYS CALCHECK FT3	Aug 27, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963182	ELECSYS CALCHECK CK-MB	Aug 23, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963147	ELECSYS CALCHECK TSH	Aug 23, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963143	ELECSYS CALCHECK TROPONIN T	Aug 23, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K963085	LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III	Aug 20, 1996	Substantially Equivalent	International Enzymes, Inc.
K962841	OPUS MYOGLOBIN CONTROLS	Aug 15, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K962694	OPUS B12 CONTROLS	Jul 22, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K962573	ELECSYS PRECICONTROL TSH	Jul 22, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962432	LIQUISPEX URINE (MICRO)ALBUMIN CONTROL	Jul 05, 1996	Substantially Equivalent	Clinical Controls, Inc.
K961510	ACS FRT4 IMMUNOASSAY	Jun 17, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K960874	COMPLEMENT CONTROL	Jun 14, 1996	Substantially Equivalent	Wako Chemicals USA, Inc.
K961206	OPUS T3 CONTROLS	Apr 23, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K960378	ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS	Apr 03, 1996	Substantially Equivalent	Actimed Laboratories, Inc.
K955629	LXN FRUCTOSAMINE TEST	Mar 20, 1996	Substantially Equivalent	Lxn Corp.
K960154	PSA CONTROLS	Mar 13, 1996	Substantially Equivalent	Diagnostic Products Corp.
K955796	IRON CALIBRATOR & CALIBRATION VERIFICATION SET	Feb 29, 1996	Substantially Equivalent	Data Medical Associates, Inc.
K955468	OPUS PROLACTIN CONTROLS	Feb 23, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K955141	OSOM HCG COMBO TEST	Dec 06, 1995	Substantially Equivalent	Wyntek Diagnostics, Inc.
K953883	ACCESS LOW LEVEL IGE CONTROLS	Nov 14, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K954144	OPUS HCG CONTROLS	Oct 06, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K952251	IMMULITE HCG HIGH LEVEL CONTROL MODULE	Sep 08, 1995	Substantially Equivalent	Diagnostic Products Corp.
K953097	OPUS T4 CONTROLS	Aug 24, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K951888	DADE STRATUS TROPONIN-I CONTROL	Jul 13, 1995	Substantially Equivalent	Dade Intl., Inc.
K944999	SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3	Jun 06, 1995	Substantially Equivalent	More Diagnostics
K950072	IMMULITE(R) TBG	Apr 03, 1995	Substantially Equivalent	Diagnostic Products Corp.
K950590	REP CHOLESTEROL PROFILE CONTROL	Mar 30, 1995	Substantially Equivalent	Helena Laboratories
K950589	CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL	Mar 20, 1995	Substantially Equivalent	Creative Laboratory Products, Inc.
K946144	LIQUISPEX(TM) URINE ETHANOL CONTROL	Feb 08, 1995	Substantially Equivalent	Clinical Controls, Inc.
K946143	CHEMSPEX(TM) AMMONIA CONTROL	Feb 03, 1995	Substantially Equivalent	Clinical Controls, Inc.
K945718	DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET	Jan 17, 1995	Substantially Equivalent	Casco Standards
K944785	SAS QUANT HCG SERUM	Jan 17, 1995	Substantially Equivalent	Sa Scientific, Inc.
K944361	DOCUMENT R AMMONIA/ETHANOL CONTROL	Nov 30, 1994	Substantially Equivalent	Casco Standards
K944453	QUANTITATE URIC ACID VERIFIER SET	Nov 22, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K944891	SAS QUANT HCG URINE	Nov 17, 1994	Substantially Equivalent	Sa Scientific, Inc.
K944515	SERUM PROTEIN CONTROLS	Nov 17, 1994	Substantially Equivalent	Pyramid Biological Corp.
K944338	DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET	Nov 15, 1994	Substantially Equivalent	Casco Standards
K942632	TNT TROPONIN T	Sep 09, 1994	Substantially Equivalent	Streck Laboratories, Inc.
K942284	CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET	Aug 26, 1994	Substantially Equivalent	Creative Laboratory Products, Inc.
K941433	HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH	Aug 02, 1994	Substantially Equivalent	Hichem Diagnostics
K935611	AXSYM LUTEINIZING HORMONE (LH)	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K940577	GLUCOMETER ELITE LOW CONTROL	Jun 13, 1994	Substantially Equivalent	Heraeus Kulzer, Inc.
K941130	ASSURE URINE HCG CONTROL	Jun 03, 1994	Substantially Equivalent	Quantimetrix Corp.
K940142	GLYCATED PROTEIN CONTROLS	Apr 26, 1994	Substantially Equivalent	Primus Corp.
K940272	ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL	Apr 20, 1994	Substantially Equivalent	Analytical Control Systems, Inc.
K940568	DOCUMENT(R) ZERO	Apr 05, 1994	Substantially Equivalent	Casco Standards
K935606	SERUM AMMONIA CONTROL	Mar 22, 1994	Substantially Equivalent	P.T. Meditrol
K933218	REFRACTOMETRIC, TOTAL PROTEIN	Feb 17, 1994	Substantially Equivalent	Pyramid Biological Corp.
K935362	P-AMYLASE CONTROL	Jan 27, 1994	Substantially Equivalent	Beckman
K934923	CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET	Dec 29, 1993	Substantially Equivalent	Unipath , Ltd.
K934922	CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET	Dec 29, 1993	Substantially Equivalent	Unipath , Ltd.
K932479	B-HCG HUMAN SERUM CONTROLS	Dec 02, 1993	Substantially Equivalent	Pyramid Biological Corp.
K934521	SPQ MALB CONTROL LEVEL II	Nov 26, 1993	Substantially Equivalent	Incstar Corp.
K932660	LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2	Oct 28, 1993	Substantially Equivalent	More Diagnostics
K933744	SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES	Sep 24, 1993	Substantially Equivalent	Sa Scientific, Inc.
K932178	AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES	Sep 21, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K930007	IMMULITE TSH THIRD GENERATION CONTROL	Aug 16, 1993	Substantially Equivalent	Diagnostic Products Corp.
K932870	DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET	Aug 02, 1993	Substantially Equivalent	Casco Standards
K932659	MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM	Jul 28, 1993	Substantially Equivalent	More Diagnostics
K932658	CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3	Jul 28, 1993	Substantially Equivalent	More Diagnostics
K932113	CANNABINOID URINE CONTROLS	Jun 29, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K931761	QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)	Jun 22, 1993	Substantially Equivalent	Quidel Corp.
K924859	AIA-PACK IGE CALIBRATION VERIFICATION TEST SET	May 14, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K930874	LD-1 CONTROL-LEVEL 1 & 2	Apr 22, 1993	Substantially Equivalent	Cala Diagnostics
K925783	AUTOSTAT ANTI-DSDNA	Mar 22, 1993	Substantially Equivalent	Cogent Diagnotics , Ltd.
K924860	AIA-PACK AFP CALIBRATION VERIFICATION TEST SET	Mar 04, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K925906	NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL	Feb 18, 1993	Substantially Equivalent	Analytical Control Systems, Inc.
K922754	TANDEM-E IGE II CALIBRATION VERIFICATION SET	Feb 17, 1993	Substantially Equivalent	Hybritech, Inc.
K925880	KODAK AMERLITE CK-MB CONTROL SERA LAN.4413	Feb 05, 1993	Substantially Equivalent	Eastman Kodak Company
K925479	SUGAR CHEX LINEARITY FOR THE ONE TOUCH	Jan 28, 1993	Substantially Equivalent	Streck Laboratories, Inc.
K926095	REFRACTROL-SP	Jan 26, 1993	Substantially Equivalent	Medical Specialties, Inc.
K924856	AIA-PACK PRL CALIBRATION VERIFICATION TEST SET	Jan 11, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K924852	ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET	Jan 11, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K924493	DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD	Jan 11, 1993	Substantially Equivalent	Casco Standards
K926015	CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3	Dec 28, 1992	Substantially Equivalent	Cala Diagnostics
K924862	AIA-PACK HCG CALIBRATION VERIFICATION TEST SET	Dec 28, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K924853	AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET	Dec 28, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K924675	TSH - THIRD GENERATION LOW CONTROLS	Nov 18, 1992	Substantially Equivalent	Nichols Institute
K924863	AIA-PACK FSH CALIBRATION VERIFICATION TEST SET	Nov 16, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K924855	AIA-PACK T-U CALIBRATION VERIFICATION TEST SET	Nov 16, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K924854	AIA-PACK PAP CALIBRATION VERIFICATION TEST SET	Nov 16, 1992	Substantially Equivalent	Tosoh Medics, Inc.
K923821	DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET	Nov 05, 1992	Substantially Equivalent	Casco Standards
K923794	DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET	Nov 05, 1992	Substantially Equivalent	Casco Standards
K923793	DOCUMENT CHEM III CALIBRATION VERIFICATION TEST	Nov 05, 1992	Substantially Equivalent	Casco Standards
K922995	LIPID CONTROLS	Aug 12, 1992	Substantially Equivalent	Creative Laboratory Products, Inc.
K922904	RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II	Jul 30, 1992	Substantially Equivalent	Reagents Applications, Inc.
K921252	TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL	Jul 17, 1992	Substantially Equivalent	Hybritech, Inc.
K920556	TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET	Jul 17, 1992	Substantially Equivalent	Hybritech, Inc.
K921206	HCG CONTROL	Apr 29, 1992	Substantially Equivalent	Polymedco, Inc.
K921089	LYPHOCHEK(R) FRUCTOSAMINE CONTROL	Apr 29, 1992	Substantially Equivalent	Bio-Rad
K915325	TSH CONTROL	Mar 02, 1992	Substantially Equivalent	Polymedco, Inc.
K915806	MILENIA DATA REDUCTION	Jan 30, 1992	Substantially Equivalent	Diagnostic Products Corp.
K914809	MP MINI PHOTOMETER	Jan 27, 1992	Substantially Equivalent	Artel, Inc.
K913585	LIPASE LINEARITY CONTROL	Oct 21, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K913792	HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL	Sep 25, 1991	Substantially Equivalent	Hichem Diagnostics
K913346	QUANTIMETRIX AMMONIA CONTROLS	Sep 25, 1991	Substantially Equivalent	Quantimetrix Corp.
K913496	CHOLINESTERASE LINEARITY CONTROL	Sep 11, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K912439	TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET	Aug 28, 1991	Substantially Equivalent	Hybritech, Inc.
K911664	DIRECTIGEN 1-2-3 PREGNANCY CONTROLS	May 31, 1991	Substantially Equivalent	Quidel Corp.
K911178	ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K911177	ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K911176	ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I	May 01, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K905280	BIOTROL BILIRUBIN C & T CONTROL	Feb 04, 1991	Substantially Equivalent	Biotrol, USA, Inc.
K904503	SERACON CR REFERENCE	Nov 02, 1990	Substantially Equivalent	Bhp Diagnostix, Inc.
K904306	DUPONT DRUG CALIBRATOR-A	Oct 15, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K903147	CHEM-CHEX-ALT	Aug 09, 1990	Substantially Equivalent	Streck Laboratories, Inc.
K902569	PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF	Aug 09, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K902760	AMERSHAM TSH CONTROL SERA	Jul 27, 1990	Substantially Equivalent	Amersham Corp.
K902867	CHEM-CHEX BILIRUBIN	Jul 16, 1990	Substantially Equivalent	Streck Laboratories, Inc.
K900719	ROTAG CONTROLS	May 30, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K896875	POSITIVE AND NEGATIVE HCG SERUM CONTROLS	Feb 26, 1990	Substantially Equivalent	Armkel, LLC
K895528	GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104	Oct 25, 1989	Substantially Equivalent	Helena Laboratories
K894400	MICRO-PLATE READER, MDX-1	Oct 23, 1989	Substantially Equivalent	Medix Biotech, Inc.
K894804	SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)	Sep 28, 1989	Substantially Equivalent	Lifescan, Inc.
K894329	RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL	Sep 05, 1989	Substantially Equivalent	Amersham Corp.
K894181	POSITIVE AND NEGATIVE HCG URINE CONTROLS	Aug 31, 1989	Substantially Equivalent	Armkel, LLC
K891475	LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3	Aug 01, 1989	Substantially Equivalent	Bio-Rad
K893140	DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET	Jun 23, 1989	Substantially Equivalent	Casco Standards
K885282	ASSAYED CHOLINESTERASE CONTROL	Jun 09, 1989	Substantially Equivalent	Actio, Inc.
K892656	DRI-DYE CHECK STRIPS (TM)-405	May 22, 1989	Substantially Equivalent	Awareness Technology, Inc.
K883741	QTEST PREGNANCY TEST CONTROL	Oct 03, 1988	Substantially Equivalent	Quidel Corp.
K883316	QUIDEL PREGNANCY TEST CONTROL	Sep 22, 1988	Substantially Equivalent	Quidel Corp.
K881430	LIQUI-SERA SERUM ALCOHOL CONTROLS	Jul 08, 1988	Substantially Equivalent	Biodiagnostic Intl
K880039	AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665	Feb 24, 1988	Substantially Equivalent	Sigma Diagnostics, Inc.
K873342	BILE ACIDS CONTROLS	Oct 20, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K873450	TRI-LEVEL LIGAND CONTROL	Sep 21, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K873105	REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL	Sep 16, 1987	Substantially Equivalent	Streck Laboratories, Inc.
K870151	TOTAL/IGE THEOPHYLLINE CONTROL SERA	Mar 12, 1987	Substantially Equivalent	3M Company
K863744	HCG CONTROL KIT	Nov 05, 1986	Substantially Equivalent	Monoclonal Antibodies, Inc.
K863126	TESTPACK ACUTE HCG SERUM CONTROLS	Sep 15, 1986	Substantially Equivalent	Abbott Laboratories
K861221	EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST	Apr 24, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860453	ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040	Feb 19, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K855225	ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL	Jan 17, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K853553	DIASCAN CONTROL	Sep 16, 1985	Substantially Equivalent	Home Diagnostics, Inc.
K851043	SUGAR-CHEX II	Apr 29, 1985	Substantially Equivalent	Streck Laboratories, Inc.
K851042	SUGAR-CHEX	Apr 29, 1985	Substantially Equivalent	Streck Laboratories, Inc.
K851079	BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3	Apr 10, 1985	Substantially Equivalent	Beckman Instruments, Inc.
K843569	PRECISET AMMONIA	Sep 28, 1984	Substantially Equivalent	Boehringer Mannheim Corp.
K833898	TRI-LEVEL BILIRUBIN CONTROLS	Jan 13, 1984	Substantially Equivalent	Sandare Chemical Co., Inc.
K833097	CHEM TRAK LIQUID BILIRUBIN CONTROL	Jan 11, 1984	Substantially Equivalent	Medical Analysis Systems, Inc.
K831523	BETA SCAN NORMAL CONTROL SOLUTION	Jul 19, 1983	Substantially Equivalent	Orange Medical Instruments, Inc.
K831527	SPINAL FLUID TOTAL PROTEIN CONTROL	Jul 18, 1983	Substantially Equivalent	Quantimetrix Corp.
K830493	PROTOPORPHYRIN ZN CONTROL	Apr 18, 1983	Substantially Equivalent	Kaulson Laboratories, Inc.
K823421	PHADEBAS HUMYLASE CONTROL(H)	Apr 05, 1983	Substantially Equivalent	Pharmacia, Inc.
K830204	DAC-CEL DIAGNATAL HCG STANDARDS RD49	Feb 18, 1983	Substantially Equivalent	Wellcome Diagnostics
K823687	BIO INTERFERENCE BLANKING MATERIAL	Jan 07, 1983	Substantially Equivalent	American Monitor Corp.
K823186	ESTROCEPT STABILIZED ESTROGEN RECEPTOR	Jan 07, 1983	Substantially Equivalent	Brl
K822219	HUMAN PLASMA CONTROL FOR CEA-ROCHE	Dec 28, 1982	Substantially Equivalent	Hoffmann-La Roche, Inc.
K823353	CARCINO-CEK	Dec 14, 1982	Substantially Equivalent	Biologics Intl., Inc.
K822938	PHADEBASE HUMYLASE CONTROL	Nov 05, 1982	Substantially Equivalent	Pharmacia, Inc.
K822698	GLUCOSCAN CONTROLS	Sep 30, 1982	Substantially Equivalent	Lifescan, Inc.
K821742	POSITIVE & NEGATIVE HCG URINE CONTROLS	Jul 02, 1982	Substantially Equivalent	Armkel, LLC
K821558	LEVEL II CONTROL SERUM	Jul 02, 1982	Substantially Equivalent	Irvine Scientific
K820772	FETAL-TEK CONTROL (IMMATURE/BORDERLINE)	May 12, 1982	Substantially Equivalent	Helena Laboratories
K812690	C-PEPTIDE CONTROL PACK	Oct 06, 1981	Substantially Equivalent	Mallinckrodt Critical Care
K811912	HELENA VMA-SMC CONTROL	Jul 23, 1981	Substantially Equivalent	Helena Laboratories
K811832	PRECINORM U & PRECIPATH U HUMAN SERUM	Jul 15, 1981	Substantially Equivalent	Boehringer Mannheim Corp.
K811150	URINE PREGNANCY TEST STANDARD/CONTR. PK	May 15, 1981	Substantially Equivalent	Mallinckrodt Critical Care
K802997	HDL-CHOLESTEROL CONTROL SERUM	Dec 22, 1980	Substantially Equivalent	Isolab, Inc.
K802068	ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO	Oct 10, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K801854	SPINAL FLUID CONTROL(HUMAN)	Sep 16, 1980	Substantially Equivalent	Environmental Chemical Specialties
K800708	CODE QAS.105 PROLACTIN CONTROL SERA	Apr 16, 1980	Substantially Equivalent	Amersham Corp.
K800035	PENTEX LIPOPROTEIN CHOLESTEROL SOLU.	Jan 21, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K792524	CK-MB (CREATINE KINASE-MB) RIA CONTROL	Jan 16, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K791957	SERACON -LO DO26	Oct 11, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K791141	BILIRUBIN CALIBRATOR CONTROL	Aug 10, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K791031	ABNORMAL PROTEIN ELECTROPHORESIS CONTROL	Jul 17, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K791029	NORMAL PROTEIN ELECTROPHORESIS CONTROL	Jul 17, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K790376	DUPONT ACA CKMB VERIFIERS	Apr 04, 1979	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K790129	SERUM PAK, HCG CONTROL	Mar 21, 1979	Substantially Equivalent	Mallinckrodt Critical Care
K782170	SERACON-LP	Feb 15, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K782171	SERACON-HDL	Feb 08, 1979	Substantially Equivalent	Bhp Diagnostix, Inc.
K772285	ACA LIPASE VERIFIERS	Jan 06, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771798	ACA BILIRUBIN CALIBRATOR	Oct 28, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771657	EMIT THYROXINE CONTROL	Oct 13, 1977	Substantially Equivalent	Syva Co.
K770795	SHAVE PREP SET	Jul 11, 1977	Substantially Equivalent	Lukens Corp.
K760885	KETOTROL-E	Nov 05, 1976	Substantially Equivalent	Sigma Chemical Co.
K760449	LIPID CONTROL	Oct 29, 1976	Substantially Equivalent	Sigma Chemical Co.