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Clinical Chemistry

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

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RecordFirmDate
ION SELECTIVE ELECTRODES & REAGENT SYS (K843008)American Monitor Corp.1984-09-04
LH RIA (K842445)Syncor Intl. Corp.1984-09-04
ROCHE STANDARDS FOR CHOLESTEROL (K843110)Roche Diagnostic Systems, Inc.1984-09-04
LABSYSTEMS FP-901 CHEMISTRY ANALYZER (K842773)Labsystems, Inc.1984-09-04
UNIVERSAL 2 S CENTRIFUGE (K843087)Boehringer Mannheim Corp.1984-08-29
EBA 3 S CENTRIFUGE (K843088)Boehringer Mannheim Corp.1984-08-29
ALLERGENTICS TOTAL IGE/THEOPHYLLINE (K842970)Allergenetics1984-08-29
SYSTEMATE CALCIUM 67214 (K843152)Em Diagnostic Systems, Inc.1984-08-29
SYSTEMATE GLUCOSE 67216 (K843150)Em Diagnostic Systems, Inc.1984-08-27
UREA ASSAY KIT (K843057)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
KEMBLE 405 (K842894)Kemble Instruments, Inc.1984-08-27
TOTAL PROTEIN ASSAY KIT (K843028)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
SYSTEMATE ALBUMIN (K843108)Em Diagnostic Systems, Inc.1984-08-27
MAGNESIUM ASSAY KIT (K843031)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
HIGH DENSITY LIPOPROTEIN PRECIPITATIN (K843029)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
SYSTEMATE TOTAL PROTEIN 67218 (K843107)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE CREATININE 67223 (K843105)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE GLUCOSE 67215 (K843151)Em Diagnostic Systems, Inc.1984-08-27
SYSTEMATE TRIGLYCERIDE 67219 (K843106)Em Diagnostic Systems, Inc.1984-08-27
INORGANIC PHOSPHORUS ASSAY KIT (K843030)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR (K841041)Miles Laboratories, Inc.1984-08-24
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (K843073)Greene International Corp.1984-08-24
DUOCLON COLOR-CEPT (K842314)Organon, Inc.1984-08-24
BETA SCAN DRYSTIX (K841369)Orange Medical Instruments, Inc.1984-08-23
TANDEM FAST VISUAL HCG ASSAY KIT - (K842633)Hybritech, Inc.1984-08-23
BETA-HCG HEMAGGLUTINATION TEST (K842181)Sero-Immuno Diagnostics, Inc.1984-08-22
QCA TRIGLYCERIDES (K842891)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-22
ZEEMAN 3030 ATOMIC ABSORPT SPECTORPHOT (K842752)The Perkin-Elmer Corp.1984-08-22
SANDARE ACID PHOSPHATASE PROCEDURE (K842516)Sandare Chemical Co., Inc.1984-08-17
ACTH STANDARD MATRIX (K842099)Diagnostic Systems Laboratories, Inc.1984-08-17
COAT-A-COUNT DHEA-SO4 RIA KIT (K842552)Diagnostic Products Corp.1984-08-17
FSH RIA (K842444)Syncor Intl. Corp.1984-08-17
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN (K842809)Technicon Instruments Corp.1984-08-17
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302 (K842519)Rna Medical Corp.1984-08-17
OSMOTIC PRESSURE AUTO & STAT OM-6010 (K842750)Kyoto Diagnostics, Inc.1984-08-17
ACA CONJUGATED BILIRUBIN ANALYTICAL (K842385)E.I. Dupont DE Nemours & Co., Inc.1984-08-17
COAT-A-COUNT DHEA RIA KIT (K842606)Diagnostic Products Corp.1984-08-17
LITHIUM REAGENT (K841847)Reagent Laboratory, Inc.1984-08-17
CHOLESTEROL ASSSAY KIT (K842160)Diagnostic Chemicals, Ltd. (Usa)1984-08-17
HICHEM ION 2/4 SERUM RANGE CALIBRATOR (K842449)Hi Chem, Inc.1984-08-16
CORTI-COTE CORTISOL SOLID PHASE RADIO (K842365)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-08-16
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE (K842393)Boehringer Mannheim Corp.1984-08-16
DATA MGMT. SYSTEM (K842500)Gilford1984-08-16
HICHEM ION 2/4 URINE RANGE CALIBRATOR (K842450)Hi Chem, Inc.1984-08-16
AMER. BIO-SCIENCE LAB CORTISOL REAGENT (K842455)American Bio-Science Laboratories1984-08-16
CREATININE ASSAY KIT-KINETIC OR ENDPOINT (K842159)Diagnostic Chemicals, Ltd. (Usa)1984-08-16
AXIOM STABLE II URIC ACID TEST (K842442)Axiom, Inc.1984-08-16
WAKO LDH CII TEST (K842452)Wako Chemicals USA, Inc.1984-08-15
TDX REA CHOLESTEROL (K842320)Abbott Laboratories1984-08-15
CLINITEK 200 SEMI-AUTOMATED URINALYSIS (K842237)Miles Laboratories, Inc.1984-08-15
ACTH NORMAL RANGE (K842249)Diagnostic Systems Laboratories, Inc.1984-08-15
TOYO JOZO URIC ACID TEST (K842103)Advocacy International, Ltd.1984-08-12
SIGMA 58-UV ASPARTATE AMINOTRANSFERAS (K842411)Sigma Chemical Co.1984-08-12
AST/GOT REAGENT SET UV RATE (K842521)Sterling Biochemical, Inc.1984-08-12
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL (K842656)Shaban Mfg. Co.1984-08-12
SIGMA 59-UV FOR ALANINE AMINOTRANSFER (K842564)Sigma Chemical Co.1984-08-12
IMMPULSE CORTISOL ASSAY REAGENTS (K842554)Aktis Corp.1984-08-12
ICP/6500 INDUCTIVELY-COUPLED PLASMA- (K842496)The Perkin-Elmer Corp.1984-08-10
SULFOSALICYLIC ACID, 3% W/V (K842915)E K Ind., Inc.1984-08-10
OPTIPHOR-10 (K842560)Gelman Sciences, Inc.1984-08-10
OPTICLEAR (K842485)Gelman Sciences, Inc.1984-08-10
ESCHWEILER COMBI-ANALYSER MTA-500 (K840961)U.S. Science, Inc.1984-08-10
AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT (K842482)Amersham Corp.1984-08-10
TOYO JOZO G-GTP TEST (K842104)Advocacy International, Ltd.1984-08-10
AMER. BIO-SCIENCE LAB T3 REAGENTS (K842590)American Bio-Science Laboratories1984-08-10
MICROSTAT GAMMA COUNTER (K842902)Micromedic Systems1984-08-09
SERUM IRON & SERUM IRON BINDING CAPACI (K842155)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
TDX REA IRON DIAGNOSTIC KIT (K842505)Abbott Laboratories1984-08-07
DHEA-S DIRECT RIA KIT (K842555)Biotecx Laboratories, Inc.1984-08-07
SERUM IRON & SERUM IRON BINDING CAPACITY (K842156)Diagnostic Chemicals, Ltd. (Usa)1984-08-07
ULTRA LYTE ANALYZER I 100 (K842315)Ultra Quest Diagnostics, Inc.1984-08-02
PDA SYSTEM (K842522)Abbott Laboratories1984-08-02
STAR HCG MONOCLONAL ANTIBODY IMMUNO (K842598)Syncor Intl. Corp.1984-07-26
CHEMISTRY ANALYZER, GEN. PURPOSE (K842311)Hml Inc/Biotechnology Transfer1984-07-25
CLINITEK 10 SEMI-AUTO URINALYSIS SYS (K842238)Miles Laboratories, Inc.1984-07-25
SYVA IQ 190 DIGITAL PIPETTER DILUTER (K842390)Syva Co.1984-07-25
AXIOM STABLE II CHOLESTEROL TEST (K842441)Axiom, Inc.1984-07-25
GLUCOSE ASSAY KIT-HEXOKINASE (K842510)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
LACTATE DEHYDROGENASE ASSAY KIT (K842507)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
CALCIUM ASSAY KIT (K842509)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
CREATINE KINASE ASSAY KIT NAC (K842508)Diagnostic Chemicals, Ltd. (Usa)1984-07-20
GLUCOSE-TRINDER-ADDAY KIT (K842506)Diagnostic Chemicals, Ltd. (Usa)1984-07-19
URIC ACID ASSAY KIT (K842246)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
ALKALINE PHOSPHATASE ASSAY KIT (K842243)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
ASPARTATE AMINOTRANSFERASE ASSAY KIT (K842245)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
UREA ASSAY KIT (K842242)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
LACTATE DENYDRO GENASE ASSAY KIT (K842244)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
ALANINE AMINOTRANSFERASE ASSAY KIT (K842241)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
ORTHO BRAND HOME PREGNANCY TEST (K842265)Advanced Care Products1984-07-17
ATAGO URINE SPECIFIC GRAVITY & SERUM (K842168)Kyoto Diagnostics, Inc.1984-07-16
SLIDE PREGNANCY TEST (K842110)Immunostics Co., Inc.1984-07-12
WAKO GLUCOSE C (K842221)Wako Pure Chemical Industries, Ltd.1984-07-12
BETA STICK, PREGNANCY TEST (K841415)Quidel Corp.1984-07-11
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (K841891)Varian Assoc., Inc.1984-07-09
TRIGLYCERIDES-GPO REAGENT (K842029)Reagents Applications, Inc.1984-07-09
TBG RIA (K842167)Syncor Intl. Corp.1984-07-09
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K842211)Em Diagnostic Systems, Inc.1984-07-06
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (K842134)Somas Medical Industries, Inc.1984-07-06
SENTECH'S ULAB 1000 CLINICAL CHEM. (K841575)Sen Tech Medical Corp.1984-07-06
KODAK EKTACHEM CONTROL (K841884)Eastman Kodak Company1984-07-06
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