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Clinical Chemistry

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

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RecordFirmDate
CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN (K792339)Connecticut Diagnostics, Ltd.1979-12-06
ELVI SGOT & SGPT TRANSAMINASE (K792410)Volu Sol Medical Industries1979-12-06
COULTER HDL CHOLESTEROL REAG. SYSTEM (K792319)Coulter Electronics, Inc.1979-12-06
AMES DEXTROMETER REFLECTANCE COLORIMETER (K792292)Miles Laboratories, Inc.1979-12-06
AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM (K792279)Micromedic Systems1979-12-06
QUANTITATIVE CONTROL URINE II (HUMAN) (K792376)Environmental Chemical Specialties1979-12-06
NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE (K792254)Nova Biomedical Corp.1979-12-06
TECHNICON C800 SYSTEM (K792285)Technicon Instruments Corp.1979-12-06
HUMAN CHORIONIC GONADOTROPIN (RIA) (K792197)Nuclear Medical Laboratories, Inc.1979-12-06
PROSTATIC ACID RADIOIMMUNOASSAY TEST (K791497)Clinical Assays, Inc.1979-12-04
ATOMIC SPECTROSCOPY SYSTEM (K792146)The Perkin-Elmer Corp.1979-11-30
HARLECO BRAND CLINICARD LIPASE TEST SET (K791922)Dade, Baxter Travenol Diagnostics, Inc.1979-11-27
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT (K792188)Abbott Laboratories1979-11-27
DURAZYME GOT/AST (K792208)American Monitor Corp.1979-11-27
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES (K792234)Boehringer Mannheim Corp.1979-11-27
FOLLICLE STIMULATING HORMONE (FSH) KIT (K792063)Cis Radiopharmaceuticals, Inc.1979-11-20
3388 REPORTING INTEGRATOR (K792158)Hewlett-Packard Co.1979-11-16
CARDIO CK-B RIA KIT (K791582)Nuclear Medical Systems, Inc.1979-11-15
PAP RIA KIT (K791735)Nuclear Medical Systems, Inc.1979-11-15
8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO (K792196)Photovolt Corp.1979-11-13
RIANEN, VITAMIN B12 ASSAY SYSTEM (K792175)New England Nuclear1979-11-13
GAS-TRAK BLOOD GAS CONTROL (K792098)United Diagnostics, Inc.1979-11-13
CENTRIA VITAMIN B12 FOLATE RADIO SET (K791216)Ventrex Laboratories, Inc.1979-11-13
NORDICLAB TOTAL ESTRIOL RIA TEST (K792189)Nordiclab Intl.1979-11-13
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (K792183)Dade, Baxter Travenol Diagnostics, Inc.1979-11-13
CORNING CONFIRM BLOOD GAS QUALITY CONTRO (K792180)Corning Medical & Scientific1979-11-13
125 I PROLACTIN HORMONE RIA KIT (K792166)Diagnostic Products Corp.1979-11-13
EMIT CLINICAL PROCESSOR-CP 5000 (K792129)Syva Co.1979-11-13
THYROID STIMULATING HORMONE (K792154)Radioimmunoassay, Inc.1979-11-13
HTSH NEONATE RIA DIAGNOSTIC KIT (K791747)Abbott Laboratories1979-11-13
125 I FOLATE SOLID PHASE RADIOASSAY (K792167)Abbott Laboratories1979-11-13
SMAC (SEQUENTIAL MULT. ANALYSIS COMP. (K792138)Fisher Scientific Co., LLC1979-11-13
MICROFLAME PHOTOMETER (K792087)Gilford Instrument Laboratories, Inc.1979-11-13
LANCER L-INA HUMAN REFERENCE SERUM (K792013)Sherwood Medical Industries1979-11-13
FISHER DIAG. PRIME BLOOD GAS CONTROLS (K792143)Fisher Scientific Co., LLC1979-11-13
PROTEIN ASSAY KIT (K790808)Specialty Medical Industries, Inc.1979-11-05
WORTHINGTON TRIGLYCERIDES REAGENT SET (K791962)Worthington Diagnostic Systems1979-11-05
RIA KIT FOR TRYPSIN (K791202)Cis Radiopharmaceuticals, Inc.1979-11-05
URIC ACID STANDARD (K792046)Gilford Diagnostics1979-10-30
LYOPHILIZED HDL CHOLESTEROL CONTROLS (K792025)Helena Laboratories1979-10-30
BIOVATION NEPHELOMETER (K792045)Biovation, Inc.1979-10-30
19091-XXXXX SER. OF GLASS CAPILLARY COL. (K791893)Hewlett-Packard Co.1979-10-30
DHEA-SULFATE TEST SET (K792041)Wien Laboratories, Inc.1979-10-30
LIPOTROL (K792024)Helena Laboratories1979-10-30
(125I) TESTOSTERONE KIT (K791999)Radioassay Systems Laboratories, Inc.1979-10-30
ESKACHEM, CK-MB REAGENT (K792023)Smithkline Diagnostics, Inc.1979-10-30
LUTEINIZING HORMONE (LH) RIA (K792000)Cis Radiopharmaceuticals, Inc.1979-10-30
PAP-CHECK RIA KIT (K792043)Serono Laboratories, Inc.1979-10-30
VMA BY COLUMN TEST (K791837)Bio-Rad1979-10-30
CORTISOL RADIOIMMUNOASSAY SYSTEM (K792036)Radioimmunoassay, Inc.1979-10-30
PREGTELL I (K792027)Central Biological Co.1979-10-30
ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS (K791373)Hoffmann-La Roche, Inc.1979-10-26
SERACON - EL DO27 (K791958)Bhp Diagnostix, Inc.1979-10-17
BE-SURE (K791706)Precision Products Corp.1979-10-17
EIA (ELISA) READER (K791968)Gilford Instrument Laboratories, Inc.1979-10-17
CENTRIA TSH RIA (K791855)Union Carbide Corp.1979-10-17
CREATININE DIAG. REAGENT PICRIC ACID (K791994)Connecticut Diagnostics, Ltd.1979-10-17
CENTRIA INSULIN RIA (K791707)Ventrex Laboratories, Inc.1979-10-17
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD (K791874)Gilford Diagnostics1979-10-17
TECHNICON C202 SYSTEM (K791989)Technicon Instruments Corp.1979-10-17
TECHNICON HDL CHOLESTEROL METHOD (K791990)Technicon Instruments Corp.1979-10-17
TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (K791431)Technicon Instruments Corp.1979-10-11
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM (K791375)Micromedic Systems1979-10-11
SERACON -LO DO26 (K791957)Bhp Diagnostix, Inc.1979-10-11
SERACON CAL D025 (K791956)Bhp Diagnostix, Inc.1979-10-11
BE-SURE (K791609)Biologics Intl., Inc.1979-10-02
LY-PRO-TROL #ACS-LP101 (K791825)Analytical Control Systems, Inc.1979-10-01
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) (K791723)Organon, Inc.1979-10-01
LDH CLINI GEL KIT (K791827)Clinical Sciences, Inc.1979-10-01
CENTRIA HPL RIA (K791854)Union Carbide Corp.1979-10-01
GLUCOSE OXIDASE (FRINDER) KIT (K791869)Mid Tech, Inc.1979-10-01
QUANTIMUNE HFSH RIA (K791836)Bio-Rad1979-10-01
CPK CLINI GEL KIT (K791826)Clinical Sciences, Inc.1979-10-01
CORTI-SHURE (K791700)Nuclear Medical Laboratories, Inc.1979-10-01
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY (K791663)Immuchem Corp.1979-10-01
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM (K791760)Fisher Scientific Co., LLC1979-09-27
AUTO PAK VITAMIN B-12 (K790347)Micromedic Systems1979-09-27
RSL'S ASSAY PROCEDURE QUANTITATION (K791728)Radioassay Systems Laboratories, Inc.1979-09-27
SERUM 11-DESOXYCORTISOL I AS TRACER (K791740)Radioassay Systems Laboratories, Inc.1979-09-27
IMMUCHEM COVALENT COAT BINDING (K791662)Immuchem Corp.1979-09-27
VENTRE/SEP T3 TEST SET (K791588)Ventrex Laboratories, Inc.1979-09-27
ESTRADIOL KIT BY RIA (K791652)Radioassay Systems Laboratories, Inc.1979-09-27
TOTAL ESTROGENS KIT BY RIA (K791651)Radioassay Systems Laboratories, Inc.1979-09-27
PTH RIA 200 (K791128)Institut National Des Radioelements1979-09-27
URIC ACID REAGENT (K791754)Gilford Diagnostics1979-09-27
CORALENT COAT 125I CORTISOL RADIOIMM. (K791835)Radioassay Systems Laboratories, Inc.1979-09-27
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY (K791664)Immuchem Corp.1979-09-27
NADH OXIDATION, AST/SGOT (K791679)American Monitor Corp.1979-09-24
INORGANIC PHOSPHORUS REAGENT (K791708)Gilford Diagnostics1979-09-24
ORTHO TSH RIA KIT (K791301)Ortho Diagnostics, Inc.1979-09-24
COULTER ACCU-ZYME II ENZYMATIC REAGENT (K791640)Coulter Electronics, Inc.1979-09-24
CONTRO I (K791695)Hi Chem, Inc.1979-09-24
GLUCOSE OXIDASE REAGENT SET (K791669)Macomb Chemical Co.1979-09-24
CONTRO II (K791696)Hi Chem, Inc.1979-09-24
SYSTEM CONTROLLER 720 SERIES (K791661)Waters Assoc., Inc.1979-09-24
SGPT REAGENT SET MODIFICATION (K791641)American Monitor Corp.1979-09-24
ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (K791712)Ventrex Laboratories, Inc.1979-09-19
CHOLORDE REAGENT (K791690)Hi Chem, Inc.1979-09-17
125I LEUTINIZING HORMONE RIA KIT (K791405)Diagnostic Products Corp.1979-09-17
NORMAL CONTROL (K791654)Electrophoresis Corp. of America1979-09-17
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