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Clinical Chemistry

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

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RecordFirmDate
FOLATE RADIOASSAY KIT (K801198)Calbiochem-Behring Corp.1980-07-21
ALBUMIN NEPHELOMETRIC ASSAY (K801362)J.T. Baker Chemical Co.1980-07-21
TOTAL PROTEIN TEST (K801061)Environmental Chemical Specialties1980-07-21
BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 (K801449)Health Diagnostics Corp.1980-07-21
MODEL 5100 ELECTROCHEMICAL DETECTOR (K801439)Environmental Sciences Assoc., Inc.1980-07-21
COBAS CK-NAC REAGENT (K801299)Roche Analytical Instruments, Inc.1980-07-14
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE (K801318)Helena Laboratories1980-07-14
BECKMAN MODEL 42 SPECTROPHOTOMETER (K801373)Beckman Instruments, Inc.1980-07-14
HIPP BUFFER(NON-BARBITAL), P/N (K801378)Gelman Sciences, Inc.1980-07-14
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT (K801409)Travenol Laboratories, S.A.1980-07-14
TEST FOR KETONE IN URINE(ACETOACETIC AC (K801270)Miles Laboratories, Inc.1980-07-08
APPLICATION OF EMIT AED ASSAYS (K801475)Syva Co.1980-07-08
SERALYZER BLOOD UREA NITROGEN(BUN) (K801269)Miles Laboratories, Inc.1980-07-08
COBAS REAGENT FOR TRIGLYCERIDES & COBAS (K801298)Roche Analytical Instruments, Inc.1980-07-08
COBAS REAGENT FOR A-AMYLASE (K801295)Roche Analytical Instruments, Inc.1980-07-08
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- (K801020)Travenol Laboratories, S.A.1980-07-08
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE (K801335)Warner-Lambert Co.1980-07-08
AVL #980 ELECTROLYTE ANALYZER (K801011)Gauntlet Technology Corp.1980-07-08
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) (K801300)E.I. Dupont DE Nemours & Co., Inc.1980-07-08
ALIZARIN SULFONATE, CALCIUM (K801290)Union Carbide Corp.1980-06-30
WAKO PHOSPHOLIPIDS TEST (K801076)Wako Pure Chemical Industries, Ltd.1980-06-30
COBAS REAGENT FOR CHOLESTEROL (K801296)Roche Analytical Instruments, Inc.1980-06-30
COBAS REAGENT FOR GLUCOSE RAPID (K801297)Roche Analytical Instruments, Inc.1980-06-30
EMIT AAII THYROXINE ASSAY (K801288)Syva Co.1980-06-30
EMIT AAII THYROXINE CALIBRATORS (K801287)Syva Co.1980-06-30
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER (K801222)Simmler, Inc.1980-06-26
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER (K801264)Nuclear Ent. , Ltd.1980-06-26
COBAS REAGENTS FOR URIC ACID (K801243)Roche Analytical Instruments, Inc.1980-06-26
COBAS REAGENT FOR AST (SGOT) (K801118)Roche Analytical Instruments, Inc.1980-06-20
COBAS REAGENT FOR ALKALINE PHOSPHATASE (K801242)Roche Analytical Instruments, Inc.1980-06-20
NUCLEAR ENTERPRISES 1612 MULTI-WELL (K801263)Nuclear Ent. , Ltd.1980-06-20
ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (K801245)New England Nuclear1980-06-20
ROCHE HCG STANDARDS (K801244)Hoffmann-La Roche, Inc.1980-06-20
TRIGLYCERIDES FOR SMA AND AAII (K801226)Reagents Applications, Inc.1980-06-20
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY (K800911)Abbott Laboratories1980-06-20
BIOSTATOR PRINTER/PLOTTER (K801210)Miles Laboratories, Inc.1980-06-17
COBAS REAGENT FOR BUN (K801116)Roche Analytical Instruments, Inc.1980-06-17
CENTRIFICHEM HDL CHOLESTEROL (K801133)Union Carbide Corp.1980-06-17
SPAC T3 RIA TEST KIT (K801125)Mallinckrodt Critical Care1980-06-09
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM (K801123)Calbiochem-Behring Corp.1980-06-09
SMI MULTI-TUBE VORTEXER (K801145)Scientific Manufacturing Industries1980-06-09
BUN-COLOR 2, BLOOD UREA NITROGEN TEST (K800902)Sclavo, Inc.1980-06-09
J.T. BAKER LSA 290 PIPETTER/DILUTER (K801090)J.T. Baker Chemical Co.1980-06-09
PERKIN ELMER MODEL 91 AMYLASE REAGENT (K801096)Stat Engineering1980-06-09
HEMOGASTAT (K801148)Therapac, Inc.1980-06-09
K 750 COMPUTER/DATA PROCESSOR (K801091)J.T. Baker Chemical Co.1980-06-09
CENTRIFICHEM SYSTEM 400 (K801167)Union Carbide Corp.1980-06-09
CORTISOL RADIOIMMUNOASSAY KIT (K801203)Technia Diagnostics , Ltd.1980-06-09
THYROXINE RADIOIMMUNOASSAY KIT (K801105)Calbiochem-Behring Corp.1980-06-09
MODEL 4900 OFF-LINE PREPARATION SYSTEM (K801271)Pm America, Inc.1980-06-09
COBAS REAGENT FOR ALT (GPT) (K801119)Roche Analytical Instruments, Inc.1980-06-09
COBAS TOTAL BILIRUBIN REAGENT & DILUENT (K801117)Roche Analytical Instruments, Inc.1980-06-09
CENTRIFICHEM SYSTEM 500 ANALYZER (K801139)Union Carbide Corp.1980-06-09
AMES GLUCOMETER REFLECT. PHOTOMETER (K801044)Miles Laboratories, Inc.1980-06-02
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- (K800689)Diagnostic Solutions, Inc.1980-05-30
REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (K800681)Diagnostic Solutions, Inc.1980-05-30
REAGENT FOR DETERM. CREATININE IN H/SERU (K800685)Diagnostic Solutions, Inc.1980-05-28
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (K800672)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. TOTAL BILIRUBIN (K800675)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. CREATINE PHOSPHOKINA (K800684)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. SODIUM IN HUMAN SUM (K800676)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS (K800690)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM (K800683)Diagnostic Solutions, Inc.1980-05-28
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA (K801037)Union Carbide Corp.1980-05-28
REAGENTS FOR DETERM. CHOLESTEROL/SERUM (K800682)Diagnostic Solutions, Inc.1980-05-28
J.T. BAKER NEPHELOMETER (K801089)J.T. Baker Chemical Co.1980-05-28
REAGENT FOR DETERM. DIRECT BILIRUBIN (K800686)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC (K800688)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. ALKALINE PHOSPHATAS (K800679)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. SERUM IRON IN HUMAN (K800677)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. LACTATE/DEHYDROGENAS (K800691)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. GLUCOSE IN H/SERUM (K800687)Diagnostic Solutions, Inc.1980-05-28
RIAUSE AUTO PROCESSOR (K801030)Electro-Nucleonics Laboratories, Inc.1980-05-28
IL MODEL 773 FLUORESCENCE LIGHT SCATTER (K801026)Instrumentation Laboratory CO1980-05-28
REAGENTS FOR DETERM. CALCIUM IN HUMAN (K800680)Diagnostic Solutions, Inc.1980-05-28
REAGENTS FOR DETERM. ALBUMIN IN HUMAN (K800678)Diagnostic Solutions, Inc.1980-05-28
REAGENT FOR DETERM. POTASSIUM/IN HUMAN (K800692)Diagnostic Solutions, Inc.1980-05-28
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM (K800673)Diagnostic Solutions, Inc.1980-05-28
SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (K800674)Diagnostic Solutions, Inc.1980-05-28
LANCER GLUCOSE RATE REAGENT KIT (K801071)Sherwood Medical Industries1980-05-23
DATA-ZYME GLUCOSE HEXOKINASE UV (K801052)Data Medical Associates, Inc.1980-05-23
IL88640 & 88641 CASSETTE-TAPE PROGRAM (K801131)Instrumentation Laboratory CO1980-05-23
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI (K801051)Data Medical Associates, Inc.1980-05-23
FERRITIRON KIT CAT. #RP-1100 (K800710)Ria Products, Inc.1980-05-14
NORDICLAB PROGESTERONE RIA TEST (K800922)Nordiclab Intl.1980-05-14
NORDICLAB TESTOSTERONE RIA TEST (K800921)Nordiclab Intl.1980-05-14
NORDICLAB ESTRADIOL RIA TEST (K800920)Nordiclab Intl.1980-05-14
HDL REAGENT (K800996)Gilford Diagnostics1980-05-14
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT (K801015)Kimble-Terumo, Inc.1980-05-14
IL SYSTEM 502 NA/K ANALYZER (K801007)Instrumentation Laboratory CO1980-05-14
TRIGLYCERIDE REAGENT (COLOR) (K801012)Gilford Diagnostics1980-05-14
ENZYMATIC TRIGLYCERIDES REAFENT FOR SMAC (K800649)Reagents Applications, Inc.1980-05-08
NO-BOIL FOLATE KIT #RP-500 (K800914)Ria Products, Inc.1980-05-08
ENZYMATIC UREA NITROGEN REAGENT SET REVI (K800719)Macomb Chemical Co.1980-05-08
FERRO-QUANT TM FE 59 TEST KIT (K800868)Mallinckrodt Critical Care1980-04-29
GAL-PUT CONTROLS, NORMAL&DEFICIENT (K800910)Sigma Chemical Co.1980-04-29
SERALYZER URIC ACID REAGENT STRIPS - (K800848)Miles Laboratories, Inc.1980-04-24
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST (K800769)Sclavo, Inc.1980-04-24
CENTRIFICHEM CHOLESTEROL (K800765)Union Carbide Corp.1980-04-24
GAMMA STICK CORTISOL RIA KIT/STICK KIT (K800538)Alpha Gamma Laboratory1980-04-24
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