Product Code: JIT FDA class 2 21 CFR 862.1150

Calibrator, Secondary

Clinical Chemistry

This device is a secondary calibrator used in clinical chemistry laboratory systems to transfer calibration values from a primary reference standard to working analytical instruments, enabling consistent and accurate measurement across testing platforms. It is classified as FDA Class 2, posing moderate risk and requiring 510(k) premarket clearance. The product code is JIT, regulated under 21 CFR 862.1150, and assigned to the Clinical Chemistry medical specialty.

View on FDA

510(k)s

245

FEI Numbers

126

Registration Numbers

126

Unique Applicants

Years Active

Research product code JIT in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JIT
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 245 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K171168	VITROS Immunodiagnostic Products Insulin Calibrators	May 16, 2017	Substantially Equivalent	Ortho Clinical Diagnostics
K170938	CalSet IGF-1	Apr 26, 2017	Substantially Equivalent	Roche Diagnostics
K170160	Abbott ARCHITECT Free T3	Feb 15, 2017	Substantially Equivalent	Abbott Laboratories
K163546	Lumipulse G Progesterone-N Calibrators	Jan 13, 2017	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K163534	Lumipulse G FSH-N Calibrators	Jan 13, 2017	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K163544	Lumipulse G Prolactin	Jan 12, 2017	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K163521	Lumipulse G LH Calibrators	Jan 12, 2017	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K163078	DC-UIBC-CAL	Dec 08, 2016	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.
K163053	Lumipulse G E2-III Calibrators	Dec 01, 2016	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K162538	ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator	Nov 17, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics
K160113	ST AIA-PACK hsE2 Calibrator Set	Feb 17, 2016	Substantially Equivalent	Tosoh Bioscience, Inc.
K153417	ST AIA-PACK PROG III Calibrator Set	Dec 18, 2015	Substantially Equivalent	Tosoh Bioscience, Inc.
K152526	Elecsys Progesterone III CalSet	Oct 02, 2015	Substantially Equivalent	Roche Diagnostics
K151566	Abbott ARCHITECT Total T4 Calibrators	Jul 10, 2015	Substantially Equivalent	Abbott Laboratories
K142985	UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator	Feb 26, 2015	Substantially Equivalent	Beckman Coulter, Inc.
K143342	Elecsys T-Uptake Calset	Dec 19, 2014	Substantially Equivalent	Roche Diagnostics
K143144	ST AIA-PACK PROG II Calibrator Set	Dec 03, 2014	Substantially Equivalent	Tosoh Bioscience, Inc.
K142181	RANDOX ALDOLASE CALIBRATION SERUM	Sep 18, 2014	Substantially Equivalent	Randox Laboratories Limited
K142021	Elecsys Estradiol III CalSet	Aug 12, 2014	Substantially Equivalent	Roche Diagnostics
K133751	DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS	Aug 08, 2014	Substantially Equivalent	Diamond Diagnostics, Inc.
K141728	ACE CALIBRATOR	Jul 28, 2014	Substantially Equivalent	SENTINEL CH. SpA
K141374	BICARBONATE CALIBRATOR	Jun 30, 2014	Substantially Equivalent	Beckman Coulter Ireland, Inc.
K140112	CA 125 II CALSET II	Jun 06, 2014	Substantially Equivalent	Roche Diagnostics
K140648	ST AIA-PACK C-PEPTIDE II CALIBRATOR SET	Apr 10, 2014	Substantially Equivalent	Tosoh Bioscience, Inc.
K130603	PATHFAST CTNL CALIBRATORS	Mar 27, 2014	Substantially Equivalent	Mitsubishi Chemical Medience Corporation
K132400	LP(A) CALIBRATORS, AND LP(A) CONTROLS	Dec 19, 2013	Substantially Equivalent	Biokit, S.A.
K130628	PATHFAST CK-MB-II CALIBRATORS	Oct 04, 2013	Substantially Equivalent	Mitsubishi Chemical Medience Corporation
K131556	DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET	Jun 26, 2013	Substantially Equivalent	Diazyme Laboratories
K130698	DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)	Apr 05, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics
K122177	ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL	Feb 15, 2013	Substantially Equivalent	Elitechgroup
K121027	DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH	Dec 20, 2012	Substantially Equivalent	Diamond Diagnostics, Inc.
K120591	DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2	Apr 17, 2012	Substantially Equivalent	Diamond Diagnostics, Inc.
K113373	DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL	Dec 30, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K111952	ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033	Aug 19, 2011	Substantially Equivalent	Beckman Coulter, Inc.
K111762	ST AIA-PACK DHEA-S CALIBRATOR SET	Aug 05, 2011	Substantially Equivalent	Tosoh Bioscience, Inc.
K111023	ABBOTT ARCHITECT LH CALIBRATORS	Jun 10, 2011	Substantially Equivalent	Abbott Laboratories
K103548	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	Jun 02, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K110169	DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H	Apr 07, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K103836	ENZYME II CALIBRATOR	Feb 16, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K103221	ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5	Dec 23, 2010	Substantially Equivalent	Roche Diagnostics
K103360	DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL	Dec 17, 2010	Substantially Equivalent	Siemens Corp.
K102638	DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS	Nov 30, 2010	Substantially Equivalent	Diazyme Laboratories
K092937	STA-HYBRID HEP CALIBRATOR	Aug 02, 2010	Substantially Equivalent	Diagnostica Stago, Inc.
K093357	DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D	Jun 24, 2010	Substantially Equivalent	Diamond Diagnostics, Inc.
K100293	ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810	Mar 19, 2010	Substantially Equivalent	Siemens Heatlhcare Diagnostics, Inc.
K092570	ABX PENTRA TPU CAL, MODEL A11A01898	Oct 16, 2009	Substantially Equivalent	HORIBA ABX SAS
K083462	DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350	Feb 27, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K082680	LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623	Oct 10, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K081789	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	Sep 10, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K082141	ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10	Sep 03, 2008	Substantially Equivalent	Biokit, S.A.
K081319	DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56	Aug 04, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K081683	LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621	Jul 07, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K080166	ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545	Mar 19, 2008	Substantially Equivalent	Beckman Coulter, Inc.
K072717	DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210	Dec 12, 2007	Substantially Equivalent	Dade Behring, Inc.
K071039	MISSION OLYMPUS AU ISE CALIBRATORS	Aug 08, 2007	Substantially Equivalent	Diamond Diagnostics, Inc.
K070552	DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)	Apr 30, 2007	Substantially Equivalent	Dade Behring, Inc.
K062521	OXALATE URINE CONTROLS (NORMAL AND ELEVATED)	Mar 16, 2007	Substantially Equivalent	Thermo-Electron Corp.
K070144	INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS	Feb 01, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K060854	ABX PENTRA 400: LIPOPROTEINS	Aug 24, 2006	Substantially Equivalent	Horiba Abx
K062152	CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27	Aug 16, 2006	Substantially Equivalent	Dade Behring, Inc.
K061885	DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250	Aug 14, 2006	Substantially Equivalent	Dade Behring, Inc.
K061818	DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)	Jul 18, 2006	Substantially Equivalent	Dade Behring, Inc.
K061751	DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260	Jul 13, 2006	Substantially Equivalent	Dade Behring, Inc.
K061702	DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)	Jul 10, 2006	Substantially Equivalent	Dade Behring, Inc.
K061139	BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS	Jul 06, 2006	Substantially Equivalent	Bayer Healthcare, LLC
K061282	ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585	Jun 02, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K060140	CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250	Apr 24, 2006	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K060754	ELECSYS TSH CALSET W/MODELS 04738551	Apr 18, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K060359	ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10	Apr 14, 2006	Substantially Equivalent	Denka Seiken Co., Ltd.
K060322	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	Mar 21, 2006	Substantially Equivalent	Cliniqa Corporation
K053291	FERRITIN CALIBRATOR SET, CATALOG NO. 8203	Mar 13, 2006	Substantially Equivalent	Reference Diagnostics, Inc.
K060371	THE EMIT 2000 TACROLIMUS CALIBRATORS	Mar 09, 2006	Substantially Equivalent	Dade Behring, Inc.
K053576	DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR	Feb 07, 2006	Substantially Equivalent	Dade Behring, Inc.
K053330	ARCHITECT B12 CALIBRATORS	Dec 16, 2005	Substantially Equivalent	Abbott Laboratories
K052148	TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET	Nov 09, 2005	Substantially Equivalent	Reference Diagnostics, Inc.
K052982	ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET	Oct 28, 2005	Substantially Equivalent	Roche Diagnostics
K052193	ISE COMPENSATOR	Oct 03, 2005	Substantially Equivalent	Roche Diagnostics
K052002	IRON STANDARD	Aug 22, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K051012	PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.	Jul 19, 2005	Substantially Equivalent	Salimetrics, LLC
K050231	ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET	Jul 06, 2005	Substantially Equivalent	Roche Diagnostics Corp.
K043378	DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT	Dec 29, 2004	Substantially Equivalent	Drew Scientific , Ltd.
K042838	VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II	Dec 09, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K042406	OLYMPUS LACTATE, OSR6193	Dec 03, 2004	Substantially Equivalent	Olympus America, Inc.
K043095	ROCHE DIAGNOSTICS ELECSYS AFP CALSET II	Nov 23, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K042521	VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS	Nov 18, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K042307	ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)	Nov 03, 2004	Substantially Equivalent	Seradyn, Inc.
K042651	FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	Oct 05, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K042490	ELECSYS FOLATE II CALSET II	Sep 30, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K033860	AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR	Apr 23, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K040692	OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023	Apr 08, 2004	Substantially Equivalent	Olympus America, Inc.
K040226	WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET	Mar 25, 2004	Substantially Equivalent	Wako Chemicals USA, Inc.
K040471	OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024	Mar 10, 2004	Substantially Equivalent	Olympus America, Inc.
K033060	CALIBRATING MATERIAL, CALIBRATING STANDARDS	Mar 04, 2004	Substantially Equivalent	Diamond Diagnostics, Inc.
K033786	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA	Feb 27, 2004	Substantially Equivalent	Ibl GmbH
K033643	CO2 CALIBRATOR/DILUENT	Jan 08, 2004	Substantially Equivalent	Bayer Healthcare, Diagnostics Division
K032458	ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT	Oct 06, 2003	Substantially Equivalent	Abbott Laboratories
K032285	OLYMPUS PREALBUMIN CALIBRATOR, ODR3029	Aug 21, 2003	Substantially Equivalent	Olympus America, Inc.
K031924	VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1	Aug 07, 2003	Substantially Equivalent	Ortho-Clinical Diagnostics
K031159	CALIBRATING MATERIAL, CALIBRATING STANDARDS	Jun 25, 2003	Substantially Equivalent	Diamond Diagnostics, Inc.
K031299	ELECSYS LH CALSET II	May 12, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K030772	RDI EXTENDED RANGE CRP CALIBRATOR SET	Apr 11, 2003	Substantially Equivalent	Reference Diagnostics, Inc.
K022533	FASTPACK TESTOSTERONE CALIBRATOR	Sep 30, 2002	Substantially Equivalent	Qualigen, Inc.
K022027	CALIBRATING MATERIAL, BUFFERS, STANDARD	Jul 22, 2002	Substantially Equivalent	Mission Diagnostics
K021607	RDI HS CRP CALIBRATOR SET	Jun 27, 2002	Substantially Equivalent	Reference Diagnostics, Inc.
K021535	ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR	Jun 27, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K021532	ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR	Jun 27, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K020980	DIMENSION TPSA CALIBRATOR, MODEL #RC459	Jun 21, 2002	Substantially Equivalent	Dade Behring, Inc.
K020723	DIMENSION ALDL CALIBRATOR, MODEL DC131	May 08, 2002	Substantially Equivalent	Dade Behring, Inc.
K020894	CALIBRATING MATERIAL, CAL-PAK, BUFFERS	Apr 29, 2002	Substantially Equivalent	Mission Diagnostics
K020454	CHEMISTRY CALIBRATOR	Apr 08, 2002	Substantially Equivalent	Jas Diagnostics, Inc.
K020596	CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS	Mar 23, 2002	Substantially Equivalent	Diamond Diagnostics, Inc.
K013850	STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE	Dec 21, 2001	Substantially Equivalent	Diamond Diagnostics, Inc.
K012900	ACCESS UNCONJUGATED ESTRIOL CALIBRATORS	Oct 16, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K012367	VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D	Oct 09, 2001	Substantially Equivalent	Nichols Institute Diagnostics
K012233	STRATUS CS TROPONIN I CALIBRATOR	Sep 11, 2001	Substantially Equivalent	Dade Behring, Inc.
K012399	MODIFICATION TO ELECSYS FSH II CALSET	Aug 24, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010332	WAKO IMMUNOASSAY CALIBRATOR SET	Aug 01, 2001	Substantially Equivalent	Wako Chemicals USA, Inc.
K010334	WAKO LIPID CALIBRATOR	Jun 25, 2001	Substantially Equivalent	Wako Chemicals USA, Inc.
K011126	RAICHEM CREATININE URINE STANDARD	May 02, 2001	Substantially Equivalent	Hemagen Diagnostics, Inc.
K010314	DIMENSION CTNI CALIBRATOR	Apr 20, 2001	Substantially Equivalent	Dade Behring, Inc.
K003501	N PROTEIN STANDARD UY CALIBRATOR	Mar 15, 2001	Substantially Equivalent	Dade Behring, Inc.
K003411	ELECSYS TESTOSTERONE CALSET II	Mar 01, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K010208	DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137	Feb 20, 2001	Substantially Equivalent	Dade Behring, Inc.
K003409	ELECSYS FSH CALSET II	Jan 26, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003096	FASTPACK CALIBRATORS	Nov 30, 2000	Substantially Equivalent	Qualigen, Inc.
K003098	ACCESS ULTRASENSITIVE HGH CALIBRATORS	Nov 20, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K000783	DIRECT TIBC CALIBRATOR	May 04, 2000	Substantially Equivalent	Reference Diagnostics, Inc.
K994291	DIMENSION SPECIAL PROTEIN CALIBRATOR	Mar 01, 2000	Substantially Equivalent	Dade Behring, Inc.
K993132	GENZYME DIRECT AMYLASE VERIFIER	Oct 04, 1999	Substantially Equivalent	Genzyme Corp.
K992981	ELECSYS ESTRADIOL CALSET II	Sep 24, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K991705	N PROTEIN STANDARD UY	Jul 15, 1999	Substantially Equivalent	Dade Behring, Inc.
K991176	OPUS TROPONIN I CALIBRATOR	Jul 01, 1999	Substantially Equivalent	Dade Behring, Inc.
K990824	REVISED C-REACTIVE PROTEIN CALIBRATOR	Apr 16, 1999	Substantially Equivalent	Dade Behring, Inc.
K990554	DIMENSION SPECIAL PROTEIN CALIBRATOR	Mar 22, 1999	Substantially Equivalent	Dade Behring, Inc.
K984193	DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR	Dec 14, 1998	Substantially Equivalent	Dade Behring, Inc.
K983850	DIMENSION AHDL CALIBRATOR	Nov 18, 1998	Substantially Equivalent	Dade Behring, Inc.
K983722	STRATUS CS TROPONIN I CALIBRATOR	Nov 04, 1998	Substantially Equivalent	Dade Behring, Inc.
K983693	DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR	Nov 04, 1998	Substantially Equivalent	Dade Behring, Inc.
K983548	FERRITIN CALIBRATOR	Oct 27, 1998	Substantially Equivalent	Dade Behring, Inc.
K981854	OLYMPUS SERUM PROTEIN MULTICALIBRATOR,	Aug 18, 1998	Substantially Equivalent	Olympus Diagnostica GmbH
K982292	PREALBUMIN CALIBRATOR	Aug 13, 1998	Substantially Equivalent	Dade Behring, Inc.
K981100	STRATUS CS TROP CALPAK	Apr 16, 1998	Substantially Equivalent	Dade Behring, Inc.
K981097	STRATUS CS CKMB CALPAK	Apr 16, 1998	Substantially Equivalent	Dade Behring, Inc.
K981101	STRATUS CS MYO CALPAK	Apr 15, 1998	Substantially Equivalent	Dade Behring, Inc.
K973668	CARDIAC TROPONIN-I (TROP) CALIBRATOR	Oct 20, 1997	Substantially Equivalent	Dade Intl., Inc.
K973100	PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR	Sep 29, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K964368	ELECSYS CEA ASSAY	Jun 16, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970336	MMB CALIBRATOR	Mar 03, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K970389	THYROID CALIBRATOR	Feb 18, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K963493	FERRITIN CALIBRATOR	Dec 03, 1996	Substantially Equivalent	Dade Chemistry Systems, Inc.
K962594	ACA PLUS FT4 CALIBRATOR	Aug 15, 1996	Substantially Equivalent	Dade Intl., Inc.
K954326	STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY	Jul 23, 1996	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K952815	DUPONT LIPASE CALIBRATOR	Aug 31, 1995	Substantially Equivalent	Dupont Medical Products
K944516	FLUIDS PACK	Nov 02, 1994	Substantially Equivalent	Alko Diagnostic Corp.
K943704	LIPASE CALIBRATOR	Sep 14, 1994	Substantially Equivalent	The DU Pont Co.
K934843	URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR	Mar 11, 1994	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K913371	TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL	Nov 08, 1991	Substantially Equivalent	Creative Laboratory Products, Inc.
K910962	CHOLESTEROL CALIBRATOR SET	Mar 29, 1991	Substantially Equivalent	Casco Standards
K910160	ELECTROPHORESIS CONTROL	Feb 27, 1991	Substantially Equivalent	Seradyn, Inc.
K904698	SECONDARY CALIBRATORS	Nov 28, 1990	Substantially Equivalent	Bionostics, Inc.
K895649	COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.	Jan 18, 1990	Substantially Equivalent	Ventrex Laboratories, Inc.
K895648	COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.	Jan 18, 1990	Substantially Equivalent	Ventrex Laboratories, Inc.
K892329	OSMOMETER STANDARD SOLUTIONS	Oct 31, 1989	Substantially Equivalent	D.R.G. Scientific Industries
K891999	CHLORIDE STANDARDS ITEM #SR1041	Aug 15, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K893139	DOCUMENT(TM) URIC ACID LINEARITY TEST SET	Jul 20, 1989	Substantially Equivalent	Casco Standards
K884197	DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET	Dec 14, 1988	Substantially Equivalent	Casco Standards
K882059	BILIRUBIN STANDARD	Oct 25, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K883306	BINAS LUTEINIZING HORMONE IRMA TEST KIT	Oct 06, 1988	Substantially Equivalent	Binax, Inc.
K882259	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	Jul 21, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K873743	PARAMAX ISE CHLORIDE CALIBRATOR	Dec 14, 1987	Substantially Equivalent	Baxter Healthcare Corp
K871759	G-GT STANDARD CALIBRATOR	Sep 29, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K872073	BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052	Sep 11, 1987	Substantially Equivalent	American Monitor Corp.
K872451	BILE ACIDS CALIBRATOR	Aug 21, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K872263	TOTAL BILIRUBIN STANDARD CALIBRATOR	Jul 22, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871756	CREATININE STANDARD SOLUTION CALIBRATOR	May 27, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871768	URIC ACID STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871767	UREA N STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871766	TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871765	PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871764	INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871763	NEFA STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871762	MAGNESIUM STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871758	GLUCOSE STANDARD SOLUTION CALIBRATOR	May 26, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K871150	ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8	May 26, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K870673	ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR	Mar 19, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K862525	EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861314	CHOLESTEROL CALIBRATORS	Jul 01, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K854784	ABSORBANCE (ABS) TEST PAK	Dec 19, 1985	Substantially Equivalent	Diagnostic Systems
K853887	LIQUI-SERA CHEM. MULTIPLE CALIBRATORS	Sep 30, 1985	Substantially Equivalent	Biodiagnostic Intl
K853533	ABSORBANCE TEST SOLUTION	Sep 16, 1985	Substantially Equivalent	Diagnostic Systems
K852461	CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET	Jul 12, 1985	Substantially Equivalent	Medical Analysis Systems, Inc.
K852067	DIRECT BILIRUBEN CALIBRATIONS	May 31, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K851670	CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/	May 10, 1985	Substantially Equivalent	Medical Analysis Systems, Inc.
K844468	TRIGLYCERIDE CALIBRATOR	Dec 11, 1984	Substantially Equivalent	Sigma Diagnostics, Inc.
K844047	FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS	Nov 09, 1984	Substantially Equivalent	Fisher Diagnostics
K843112	ROCHE STANDARDS FOR URIC ACID	Sep 13, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K842099	ACTH STANDARD MATRIX	Aug 17, 1984	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K840772	ALCOHOL & AMMONIA CALIBRATOR II	Apr 13, 1984	Substantially Equivalent	American Dade
K840771	ALCOHOL & AMMONIA CALIBRATOR I	Apr 13, 1984	Substantially Equivalent	American Dade
K840775	CARBON DIOXIDE CALIBRATOR II	Apr 04, 1984	Substantially Equivalent	American Dade
K840774	CARBON DIOXIDE CALIBRATOR I	Apr 04, 1984	Substantially Equivalent	American Dade
K840218	TRIGLYCERIDE AQUEOUS STANDARDS	Mar 23, 1984	Substantially Equivalent	Preventive Diagnostics Corp.
K833702	ACA THYROXINE UPTAKE CALIBRATOR	Jan 04, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833700	ACA THYROXINE CALIBRATOR	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832094	BILIRUBIN CALIBRATORS & CONTROL	Aug 11, 1983	Substantially Equivalent	Gilford Diagnostics
K830469	BILIRUBIN STANDARD-LYOPHILIZED	Mar 24, 1983	Substantially Equivalent	Dow Instruments & Reagents, Inc.
K823025	KM - KAL 2	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823024	KM - KAL 1	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823023	KM-KAL L6	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823022	KM-KAL 6	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823021	KM - KAL 5	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823020	KM-KAL 4	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K823019	KM-KAL 3	Nov 16, 1982	Substantially Equivalent	Kmn Products, Inc.
K822852	TRIGLYCERIDE CALIBRATOR	Oct 27, 1982	Substantially Equivalent	Harleco Diagnostics
K822496	SERA CHEM SMAC CALIBRATORS	Sep 21, 1982	Substantially Equivalent	Fisher Scientific Co., LLC
K822479	BILIRUBIN CALIBRATOR #65071	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822478	ALBUMIN STANDARD, #65070	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822475	TOTAL PROTEIN STANDARD, #65074	Sep 14, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K822334	BILIRUBIN CALIBRATORS	Sep 02, 1982	Substantially Equivalent	Gilford Diagnostics
K802823	CHOLESTEROL STANDARDS	Dec 11, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K800770	SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT	Apr 21, 1980	Substantially Equivalent	Sclavo, Inc.
K800220	CALIBRATOR NO. 1 & 2, & WASH SOLUTION	Feb 26, 1980	Substantially Equivalent	Fisher Scientific Co., LLC
K792290	TSH STANDARDS & DILUENT	Dec 06, 1979	Substantially Equivalent	Amersham Corp.
K791312	CATALOG #4-2520 CHLORIDOMETER CHLORIDE	Aug 16, 1979	Substantially Equivalent	Buchler Instruments, Inc.
K781423	DUAL COMPONENT STANDARDS	Aug 31, 1978	Substantially Equivalent	Abbott Laboratories
K781071	STANDARDS, HORMONE, THYROID STIMULATING	Aug 14, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K781069	T3 STANDARDS IN HUMAN SERUM	Aug 14, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K781072	TRAP-BLOOD VESSEL STABILIZATION DEVICE	Aug 10, 1978	Substantially Equivalent	Ayer, Patrick, M.D.
K780447	URIC ACID REFERENCE SERA	Jun 22, 1978	Substantially Equivalent	Macomb Chemical Co.
K780295	CALIBRATORS, CARBON DIOXIDE	Apr 05, 1978	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K772153	FLAME PHOTOMETER STANDARD	Feb 28, 1978	Substantially Equivalent	Alko Scientific Co.
K772106	PH CALIBRATION BUFFERS	Dec 06, 1977	Substantially Equivalent	General Diagnostics
K771804	ACA AMMONIA CALIBRATOR	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771803	ACA PHOSPHORUS CALIBRATOR	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771802	ACA IRON CALIBRATOR	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771801	ACA CARBON DIOXIDE CALIBRATOR	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771797	ACA TRIGLYCERIDE CALIBRATOR	Oct 25, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771216	CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET	Jul 21, 1977	Substantially Equivalent	Union Carbide Corp.
K771215	CENTRIFICHEM TRIGLYCERIDE CALI. STD.	Jul 21, 1977	Substantially Equivalent	Union Carbide Corp.
K771143	INORGANIC PHOSPHORUS STANDARDS	Jul 11, 1977	Substantially Equivalent	Worthington Biochemical Corp.
K770277	CHOLESTEROL STANDARDS	Mar 01, 1977	Substantially Equivalent	Worthington Biochemical Corp.
K770127	CENTRIFICHEM 200MG/DL CHOL. CAL. STD.	Jan 31, 1977	Substantially Equivalent	Union Carbide Corp.
K770126	CENTRIFICHEM CHOLES. CALIB. STD. SET	Jan 31, 1977	Substantially Equivalent	Union Carbide Corp.
K761197	CHOLESTEROL CALIBRATOR	Dec 21, 1976	Substantially Equivalent	Beckman Instruments, Inc.
K760349	BILIRUBIN REF., SIGMA STOCK NO. 605-10	Oct 05, 1976	Substantially Equivalent	Sigma Chemical Co.