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Clinical Chemistry

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

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RecordFirmDate
LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT (K872324)Berthold Analytical Instruments, Inc.1987-08-19
ABBOTT BIOTELL PREGNANCY TEST (K871996)Abbott Laboratories1987-08-18
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) (K872306)Boehringer Mannheim Corp.1987-08-18
IMMUBEAD THYROID UPTAKE (K872172)Immunotech Corp.1987-08-17
TRIGLYCERIDE (UV) REAGENT (K872912)Sigma Chemical Co.1987-08-17
NOVOCHECK/CHECKPOINT/CONTROL SOLUTION (K872049)Garid, Inc.1987-08-13
CARBON DIOXIDE (K872886)Catachem, Inc.1987-08-13
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT (K872197)Sigma Diagnostics, Inc.1987-08-13
BIOTROL ALT/TGP MONOREACTIF (K872830)Biotrol, USA, Inc.1987-08-13
CALCITONIN RIA KIT (K872880)Endocrine Associates, Inc.1987-08-13
EASY ST ANALYZER SYSTEM (K872813)Em Diagnostic Systems, Inc.1987-08-13
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT (K872191)Immunotech Corp.1987-08-13
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL (K871265)E.I. Dupont DE Nemours & Co., Inc.1987-08-13
IMMUBEAD T4 ENZYME IMMUNOASSAY KIT (K872192)Immunotech Corp.1987-08-13
BIOTROL AST/TGO MONOREACTIF (K872829)Biotrol, USA, Inc.1987-08-13
ION TRAP DETECTOR (ITD) (K872464)The Perkin-Elmer Corp.1987-08-11
CENTRICELL(TM) (K871290)Polysciences, Inc.1987-08-05
CLEARPLAN (K871332)Unipath , Ltd.1987-08-05
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE (K872727)Serono Diagnostics, Inc.1987-08-05
AMYLASE TEST KIT (K872023)Ciba Corning Diagnostics Corp.1987-08-05
LIPID CONTROL SERUM (K872376)Biological Industries1987-08-05
BINAX IRMA TOTAL BETA-HCG TEST KIT (K872728)Binax, Inc.1987-08-05
MICROMI-CK(TM) (K872598)Intl. Immunoassay Laboratories, Inc.1987-08-03
MICROMEDIC COMBOSTAT LH/FSH KIT (K872309)Micromedic Systems1987-07-31
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. (K872897)Serono Diagnostics, Inc.1987-07-31
IMACK-MB(TM) (K872592)Intl. Immunoassay Laboratories, Inc.1987-07-31
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (K872196)American Dade1987-07-31
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE (K872716)Ciba Corning Diagnostics Corp.1987-07-31
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 (K872320)Em Diagnostic Systems, Inc.1987-07-27
OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) (K871726)Monoclonal Antibodies, Inc.1987-07-27
DIABETES RISK DETECTOR (K864544)Pearce Clinical Laboratories, Inc.1987-07-27
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 (K872322)Em Diagnostic Systems, Inc.1987-07-27
TOTAL BILIRUBIN STANDARD CALIBRATOR (K872263)Wako Chemicals USA, Inc.1987-07-22
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH (K872627)Serono Diagnostics, Inc.1987-07-21
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS (K872511)Catachem, Inc.1987-07-21
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY (K872286)Ciba Corning Diagnostics Corp.1987-07-21
TDXR FETAL LUNG MATURITY (K871593)Abbott Laboratories1987-07-20
DYNATECH SPD 3000, #002-900-0000 (K872363)Dynatech Laboratories, Inc.1987-07-16
V-MARC 88A COMPUTER (K871853)V.Marc, A Div. of Pictorial, Inc.1987-07-16
CHOLESTEROL REAGENT (K872295)Sigma Diagnostics, Inc.1987-07-16
HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM (K872582)Millipore Corp.1987-07-16
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES (K872130)Syva Co.1987-07-16
HDL CHOLESTEROL REAGENT (K872575)Sigma Chemical Co.1987-07-16
HCG MAB SOLID PHASE COMPONENT SYSTEM (K871700)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-15
HITACHI 717 CHEMISTRY ANALYZER (K872494)Boehringer Mannheim Corp.1987-07-09
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT (K872311)Abbott Laboratories1987-07-09
DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (K871977)American Dade1987-07-09
AFFINITY(TM) I UPTAKE IMMUNIT(TM) (K865083)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-07-09
UNI-FAST LACTATE DEHYDROGENASE (LDH-L) (K872030)Sclavo, Inc.1987-07-07
UNASSAYED CONTROL SERUM, NORMAL (BOVINE) (K872304)Vanguard Diagnostic Systems1987-07-07
UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) (K872303)Vanguard Diagnostic Systems1987-07-07
PARAMAX CHOLESTEROL REAGENT (K872050)American Dade1987-07-07
LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II (K872227)Bio-Rad1987-07-06
PFI-20 POLARIZING FLUORIMETER (K871550)The Perkin-Elmer Corp.1987-07-01
EASY-TEST AMMONIA (AMON) ITEM NO. 16695 (K872110)Em Diagnostic Systems, Inc.1987-07-01
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX (K872305)Diagnostic Products Corp.1987-07-01
MODIFIED SALTEX REAGENT STRIPS (K870214)Miles Laboratories, Inc.1987-06-29
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER (K872190)Nova Biomedical Corp.1987-06-24
KODAK EKTACHEM 700XR ANALYZER (K872105)Eastman Kodak Company1987-06-23
ULTRA-VIOLET BUN REAGENT KIT (RATE) (K871547)Biochemical Trade, Inc.1987-06-22
ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. (K871543)Catachem, Inc.1987-06-22
CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K870969)Canadian Bioclinical, Ltd.1987-06-22
TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K870968)Canadian Bioclinical, Ltd.1987-06-22
TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II (K872063)Hybritech, Inc.1987-06-19
KODAK EKTACHEM 700S ANALYZER (K872103)Eastman Kodak Company1987-06-17
DELFIA(TM) THYROXINE (T4) KIT (K871303)Lkb Instruments, Inc.1987-06-17
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT (K872177)Nuclear Diagnostics, Inc.1987-06-17
UNI-FAST CREATINE KINASE TEST (CK) (K872029)Sclavo, Inc.1987-06-17
TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER (K871892)Technicon Instruments Corp.1987-06-17
KODAK EKTACHEM 700P ANALYZER (K872104)Eastman Kodak Company1987-06-17
8000 SERIES GAS CHROMATOGRAPHS (K872122)The Perkin-Elmer Corp.1987-06-17
ABBOTT SPECTRUM BICARBONATE REAGENT KIT (K872108)Abbott Laboratories1987-06-17
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS (K872079)Reagents Applications, Inc.1987-06-15
SIGMA'S CALCIUM PROCEDURE NO. 587 (K871152)Sigma Diagnostics, Inc.1987-06-12
MICROCHECK LH OVULATION TEST (K871602)Syntron Bioresearch, Inc.1987-06-11
IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (K871973)Instrumentation Laboratory CO1987-06-11
GAMMA GLUTAMYLTRANSFERASE REAGENT (K871979)Intersect Systems, Inc.1987-06-11
ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT (K871308)Allelix, Inc.1987-06-11
MULTICHEM LDH-L REAGENT (K872010)Simmler, Inc.1987-06-11
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) (K870405)Diagnostic Systems Laboratories, Inc.1987-06-08
MULTICHEM TOTAL PROTEIN REAGENT #S0928 (K871975)Simmler, Inc.1987-06-05
MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 (K871976)Simmler, Inc.1987-06-05
ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) (K871780)Biochemical Trade, Inc.1987-06-04
BILIRUBIN TESTER (K870095)Wako Chemicals USA, Inc.1987-06-03
ANALYZER: NOVA STAT PROFILE 3 ANALYZER (K871397)Nova Biomedical Corp.1987-06-03
D.A.T. (TM) AMYLASE REAGENT (K871943)Behring Diagnostics, Inc.1987-06-03
THE URIC ACID REAGENT SET (K871902)Macomb Biotechnology, Inc.1987-06-03
TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT (K871235)Hybritech, Inc.1987-06-03
ULTRAVIOLET LACTATE DEHYDROGENASE REAGENT SET (K871781)Biochemical Trade, Inc.1987-06-03
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 (K870746)Stanbio Laboratory1987-06-01
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT (K870890)Helena Laboratories1987-06-01
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (K871185)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60081 120 NA/2K (K871182)In Vitro Diagnostics, Inc.1987-05-28
CIBA CORNING MODEL 664/FAST 4 SYSTEM (K871028)Ciba Corning Diagnostics Corp.1987-05-28
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (K871187)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60082 140 NA/5K (K871183)In Vitro Diagnostics, Inc.1987-05-28
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 (K871188)In Vitro Diagnostics, Inc.1987-05-28
CESIUM DILUENT 1.5 MMOL CS/L #60087 (K871186)In Vitro Diagnostics, Inc.1987-05-28
AFFINITY (TM) HCG IMMUNIT (TM) (K870627)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-28
FLAME PHOTOMETER STANDARD #60083 160 NA/8K (K871184)In Vitro Diagnostics, Inc.1987-05-28
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