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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATION (K921937)Nova Biomedical Corp.1992-07-27
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (K922024)Helena Laboratories1992-07-23
IL TEST BILIRUBIN TOTAL/DIRECT (K920653)Instrumentation Laboratory CO1992-07-23
AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K923021)Tosoh Corp.1992-07-21
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION (K922139)Syva Co.1992-07-21
VISTA ULTRASENSITIVE HTSH ASSAY (K922138)Syva Co.1992-07-21
WAKO AUTOKIT LIPASE-COLOR (K921249)Wako Chemicals USA, Inc.1992-07-21
OLYMPUS ISE MODULE (K921718)Olympus Corp.1992-07-21
KODAK EKTACHEM DT SLIDES (NBIL) (K921844)Eastman Kodak Company1992-07-21
SYNERMED UIBC REAGENT KIT (K922784)Synermed, Inc.1992-07-21
NOVA 14 NA/K/CL/GLU/BUN ANALYZER (K922215)Nova Biomedical Corp.1992-07-17
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL (K921252)Hybritech, Inc.1992-07-17
OLYMPUS ALBUMIN REAGENT (K922369)Olympus Corp.1992-07-17
OLYMPUS URIC ACID REAGENT (K922756)Olympus Corp.1992-07-17
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET (K920556)Hybritech, Inc.1992-07-17
STAT K SYSTEM (K915345)Portable Diagnostic Services, Inc.1992-07-16
OLYMPUS TOTAL PROTEIN REAGENT (K922361)Olympus Corp.1992-07-16
OLYMPUS GLUCOSE REAGENT (K922232)Olympus Corp.1992-07-16
KING DIAGNOSTICS AST (GOT) REAGENT (K922108)King Diagnostics, Inc.1992-07-15
WAKO AUTOKIT MICRO TP (K920531)Wako Chemicals USA, Inc.1992-07-14
BLOOD GAS/ISE LINEARITY CONTROL (K920285)Phoenix Diagnostics, Inc.1992-07-14
OLYMPUS CREATINE KINASE REAGENT (K922459)Olympus Corp.1992-07-13
DSL ACTIVE ALDOSTERONE (DSL 8600) (K921205)Diagnostic Systems Laboratories, Inc.1992-07-10
KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA (K922736)Eastman Kodak Company1992-07-10
KODAK EKTACHEM 250 ANALYER (K922072)Eastman Kodak Company1992-07-10
ELEGANCE FT4 ELISA (K922284)Bioclone Australia Pty , Ltd.1992-07-10
OLYMPUS CALCIUM REAGENT (K922233)Olympus Corp.1992-07-10
CORTISOL CHEMILUMINESCENCE ASSAY (K922676)Nichols Institute1992-07-10
OLYMPUS UREA NITROGEN (BUN) REAGENT (K922597)Olympus Corp.1992-07-10
ANGEL WING SETS -- MODIFIED (K922468)Mbo Laboratories, Inc.1992-07-10
VACUTAINER BRAND LUER ADAPTER (K921520)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-07-10
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 (K922046)Bio-Rad1992-07-10
SINGLE-STEP PREGNANCY, HCG TEST (K922290)American Medical Products, Inc.1992-07-09
ROCHE REAGENT FOR URIC ACID--MODIFICATION (K922762)Roche Diagnostic Systems, Inc.1992-07-09
THYROXINE (T4) COATED TUBE RIA (K921935)Monobind1992-07-07
DADE URINE CHEMISTRY CONTROL LEVELS I AND II (K920636)Baxter Diagnostics, Inc.1992-07-07
OLYMPUS TRIGLYCERIDE REAGENT (K922229)Olympus Corp.1992-07-02
ELISA TUBE TSH TEST (K921958)Bio Clinic Co.1992-07-02
RNA MEDICAL'S EQUIL 55 (K922357)Bionostics, Inc.1992-06-30
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER (K921661)Boehringer Mannheim Corp.1992-06-30
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (K921700)Medix Biotech, Inc.1992-06-29
RNA MEDICAL TONOMETER (K922386)Bionostics, Inc.1992-06-26
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER (K922220)Olympus Corp.1992-06-25
MILENIA FOLIC ACID (K921614)Diagnostic Products Corp.1992-06-25
OLYMPUS GGT REAGENT (K922230)Olympus Corp.1992-06-25
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE (K922612)Cholestech Corp.1992-06-24
THYROXINE (FPIA) KIT (K921904)Tudor Laboratories, Inc.1992-06-24
BACTON(TM), AUTO-APO A-1 REAGENT (K921795)Bacton Assay Systems, Inc.1992-06-23
BACTON(TM), AUTO-APO B REAGENT (K921862)Bacton Assay Systems, Inc.1992-06-22
BACTIDROP ACRIDINE ORANGE (K920974)Remel Co.1992-06-19
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 (K920927)Helena Laboratories1992-06-19
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY (K921816)Biomerieux Vitek, Inc.1992-06-18
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921746)Biomerieux Vitek, Inc.1992-06-16
ROCHE CALIBRATOR SERUM (K922043)Roche Diagnostic Systems, Inc.1992-06-16
CEDIA RED BLOOD CELL FOLATE REAGENT PACK (K921689)Microgenics Corp.1992-06-16
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942)Olympus Corp.1992-06-10
ORS-100 (K921568)Mnlase, Inc.1992-06-09
CIBA CORNING ACS FOLATE IMMUNOASSAY (K921678)Ciba Corning Diagnostics Corp.1992-06-09
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 (K921286)Bio-Rad1992-06-09
IMMULITE(R) FSH (K921704)Cirrus Diagnostics, Inc.1992-06-09
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K921763)Hybritech, Inc.1992-06-09
ORS-200 (K921569)Mnlase, Inc.1992-06-09
ORS-300 (K921570)Mnlase, Inc.1992-06-09
KING DIAGNOSTICS ALT (GPT) REAGENT (K922109)King Diagnostics, Inc.1992-06-04
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST (K921099)Syntron Bioresearch, Inc.1992-05-29
DIRECTDRAW SUPERSERUM (K921778)International Technidyne Corp.1992-05-28
BIOTROL MAGNESIUM (MAGON) (K921677)Biotrol, USA, Inc.1992-05-26
DSL DHEA (DSL 8900) (K921534)Diagnostic Systems Laboratories, Inc.1992-05-26
THYROXINE CALIBRATOR KIT (K921903)Tudor Laboratories, Inc.1992-05-26
APOLIPOPROTEIN TEST SYSTEM (K921037)Baxter Diagnostics, Inc.1992-05-22
N-TACT(R) PTH SP KIT (K921629)Incstar Corp.1992-05-14
CALCIUM-ARSENAZO III REAGENT SET (K921625)Pointe Scientific, Inc.,1992-05-13
KEMTROL SERUM CONTROL-ABNORMAL (K920926)Helena Laboratories1992-05-07
SYNERMED ALT/GPT REAGENT KIT (K921016)Synermed, Inc.1992-05-07
IMX INSULIN (K920109)Abbott Laboratories1992-05-07
MIRCO ELISA HPL TEST KIT (K921212)Bio Clinic Co.1992-05-07
NOW PREGNANCY TEST KIT (K921211)Bio Clinic Co.1992-05-07
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (K915896)Dynatech Laboratories, Inc.1992-05-04
VACUTAINER(R) BRAND SST(R) AND CAT TUBES (K921806)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
ROCHE COBAS MIRA PLUS (K920402)Roche Diagnostic Systems, Inc.1992-04-29
AUTOLOADER (K921005)Innovative Medical Systems, Inc.1992-04-29
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (K921455)E.I. Dupont DE Nemours & Co., Inc.1992-04-29
ELECTRODE, ION SPECIFIC (K915675)Alko Diagnostic Corp.1992-04-29
LYPHOCHEK(R) FRUCTOSAMINE CONTROL (K921089)Bio-Rad1992-04-29
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET (K921636)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
HCG CONTROL (K921206)Polymedco, Inc.1992-04-29
SLT SPECTRA (K915689)Slt Labinstruments, Inc.1992-04-22
MYDAS(TM)-MB2/MYDAS(TM)-MB (K913380)Intl. Immunoassay Laboratories, Inc.1992-04-22
SLT 340 ATTC (K915690)Slt Labinstruments, Inc.1992-04-22
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD (K920809)King Diagnostics, Inc.1992-04-17
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K920940)Eastman Kodak Company1992-04-17
T4 EIA BEAD ASSAY (K920766)Tech-Co, Inc.1992-04-17
ULTRA+ BLOOD GLUCOSE TEST STRIP (K915770)Home Diagnostics, Inc.1992-04-14
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP (K915772)Home Diagnostics, Inc.1992-04-14
ELISA TUBE PROLACTIN TEST KIT (K920921)Bio Clinic Co.1992-04-08
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921176)Vitek Systems, Inc.1992-04-08
ELISA TUBE LH TEST KIT (K920920)Bio Clinic Co.1992-04-08
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG (K921012)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-08
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL (K920826)Eastman Kodak Company1992-04-07
TMB CHROMOGEN/SUBSTRATE REAGENT SET (K920918)Bio Clinic Co.1992-04-07
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