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Clinical Chemistry

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

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RecordFirmDate
EMIT CLINICAL PROCESSOR - CP 5000 (K780881)Syva Co.1978-06-22
BIOSTATOR GLUCOSE ANALYZER (K780393)Miles Laboratories, Inc.1978-06-19
B-HCG-RIA (K780679)Nuclear Medical Systems, Inc.1978-06-14
DILUTOR TRANSPORTER (K780785)Hyland Therapeutic Div., Travenol Laboratories1978-06-14
TECHNICON BGII ANALYZER (K780716)Technicon Instruments Corp.1978-06-14
T4-RIA KIT (K780707)Clinical Bioresearch1978-06-14
SGPT/ALT REAGENT SYSTEM (K780791)American Monitor Corp.1978-06-13
URIC ACID RAPID STAT KIT (K780827)Pierce Chemical Co.1978-06-13
ISOZYME - ID CPK MARKER (K780801)Dade, Baxter Travenol Diagnostics, Inc.1978-06-13
TSH RIA KIT (K780726)Amersham Corp.1978-06-13
NINHYDRIN REAGENT KIT (K780847)Beckman Instruments, Inc.1978-06-13
ARMTROL AND FERMTROL (K780802)Biotron , Ltd.1978-06-13
PERALISTIC PUMP MODEL 2000 (K780789)Innovative Medical Systems, Inc.1978-06-13
TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (K780792)The Upjohn Co.1978-06-13
VITAMIN B12 RADIOASSAY (K780799)Amersham Corp.1978-06-13
HDL CHOLESTEROL (K780659)Macomb Chemical Co.1978-06-13
125 I-T3 UPTAKE REAGENT (K780671)Radioimmunoassay, Inc.1978-06-06
KRYORACK/4 (K780757)Streck Laboratories, Inc.1978-06-06
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT (K780783)J.T. Baker Chemical Co.1978-06-06
125 I-T4 RIA REAGENT (K780672)Radioimmunoassay, Inc.1978-06-06
CENTRIA CORTISOL RIA (K780725)Union Carbide Corp.1978-06-06
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT (K780787)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-06-06
CLIN. CHEM. CONTROL SERUM-QUANTITATE (K780554)Beckman Instruments, Inc.1978-06-06
THERMAJUST CIRCU-TEMP (K780543)Techhnilab Instruments, Inc.1978-05-26
SR-PLUS DIRECT CHOLESTEROL TEST (K780545)Stanbio Laboratory1978-05-26
TRIGLYCERIDE C-37 RAPID STAT KIT (K780825)Pierce Chemical Co.1978-05-26
DYNEX BLOOD GAS QUALITY CONTROL SYS. (K780144)Analytical Products, Inc.1978-05-26
ACCESSORY HDL CHOLESTEROL REAGENT SET (K780638)The Dow Chemical Co.1978-05-26
BILIRUBIN RAPID STAT KIT (K780826)Pierce Chemical Co.1978-05-26
FLAME PHOTOMETER, MODEL 455 (K780650)Corning Medical & Scientific1978-05-26
SCINTILLATION, LIQUID, RACKBETA (K780341)Lkb Instruments, Inc.1978-05-26
TOTAL IRON BINDING CAPACITY (K780412)Diagnostic Corp. of America1978-05-26
FLAME PHOTOMETER, MODEL 435 (K780649)Corning Medical & Scientific1978-05-26
REAGENT SET HDL CHOLESTEROL (K780635)Boehringer Mannheim Corp.1978-05-19
ULTRACHEM ENZYMATIC CHOLESTEROL 65025 (K780523)Harleco1978-05-19
ULTRACHEM T-BILI 64971 GILFORD 3500 (K780524)Harleco1978-05-19
COMP. CLIN. CHEM. CONTROL SERUM-DECISION (K780552)Beckman Instruments, Inc.1978-05-19
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM (K780515)Harleco1978-05-19
UREA NITROGEN (ENZYMATIC) (K780534)Macomb Chemical Co.1978-05-19
T-3 UPTAKE (SORBENT) KIT (K780525)Amersham Corp.1978-05-19
125-I LABELED HUMAN LUTEINIZING HORMONE (K780576)Pcl-Ria, Inc.1978-05-19
ALFATEST (K780542)Panmed, Inc.1978-05-19
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 (K780513)Harleco1978-05-19
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK (K780553)Beckman Instruments, Inc.1978-05-19
ULTRACHEM CREATININE 64972, CENTRIFUCHEM (K780514)Harleco1978-05-19
FOLATE REAGENT KIT, ARIA-II SYSTEM (K780557)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-05-18
SINGLE VIAL 10 SGOT-TRIS (K780634)Boehringer Mannheim Corp.1978-05-18
SINGLE VIAL 10 SGPT-TRIS (K780636)Boehringer Mannheim Corp.1978-05-18
SPECTROPHOTOMETERS, ATOMIC ABSORPTION (K780522)Instrumentation Laboratory CO1978-05-12
SPECTROPHOTOMETER, ATOMIC ABSORPTION (K780521)Instrumentation Laboratory CO1978-05-12
DATA-ZYME TRIGLYCERIDE PROCEDURE (K780379)Data Medical Associates, Inc.1978-05-12
AST(GOT) UNI-UV, SGOT (K780463)Sclavo, Inc.1978-05-12
ALT(GPT) UNI-UV, SGPT (K780462)Sclavo, Inc.1978-05-12
CBR-T3RIA KIT (K780499)Clinical Bioresearch1978-05-04
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (K780507)Gamma Enterprises, Inc.1978-05-03
AUTO/STAT KIT (K780512)Pierce Chemical Co.1978-05-03
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (K780505)Gamma Enterprises, Inc.1978-05-03
CBR-T3 UPTAKE KIT (K780500)Clinical Bioresearch1978-05-03
CREATINE PHOSPHOKINASE (CPK) (K780504)Gamma Enterprises, Inc.1978-05-03
EMIT CENTRIFICHEM THYROXINE ASSAY (K780639)Syva Co.1978-05-03
LYPOPROTEIN CHOLESTEROL TEST KIT (K780173)Environmental Chemical Specialties1978-05-03
KOVA TROL III (K780482)Icl Scientific1978-05-03
CARBON DIOXIDE REAGENTS (K780506)Gamma Enterprises, Inc.1978-05-03
LELECTIVE KINETIC SYSTEM-60 (K780464)Hycel, Inc.1978-05-03
QUANTITOPE 125I-FOLATE RADIOASSAY KIT (K780508)Kallestad Laboratories, Inc.1978-05-03
RADIOASSAY FOR TOTAL SERUM THYROXINE (K780644)Nuclear Diagnostics, Inc.1978-04-28
STIKSEP-T3 KIT (K780486)Nuclear Diagnostics, Inc.1978-04-28
STAC SYSTEM (K780373)Technicon Instruments Corp.1978-04-28
GAMMA STIK 125I T3 UPTAKE KIT (K780492)Alpha Gamma Laboratory1978-04-28
RIA SYS. FOR HUMAN LUTEINIZING HORMONE (K780367)Calbiochem-Behring Corp.1978-04-28
NORMAL UNASSAYED CONTROL SERA (K780351)Macomb Chemical Co.1978-04-24
THYRO-ZYME-T4 ASSAY KIT (K780401)Coulter Electronics, Inc.1978-04-24
SGOT/AST REAGENT SYSTEM (K780443)American Monitor Corp.1978-04-24
EMIT ANTIEPILEPTIC DRUG CALIBRATORS (K780467)Syva Co.1978-04-24
DISC-PAK ROTATOR (K780544)Techhnilab Instruments, Inc.1978-04-24
HDL REAGENT SET FOR LIPOPROTEINS (K780389)Worthington Biochemical Corp.1978-04-19
SINGLE VIAL LACTATE (K780563)Boehringer Mannheim Corp.1978-04-18
PRECIMAT GLYCEROL (K780439)Boehringer Mannheim Corp.1978-04-18
AUTO. WELL TYPE GAMMA COUNTERS (K771614)Actus, Inc.1978-04-12
GAMMA COUNTER (K780344)Lkb Instruments, Inc.1978-04-12
OREIA-T4 (K780308)Organon, Inc.1978-04-12
MODULAR SCANNING DENSITOMETER SYS. (K780318)Transidyne General Corp.1978-04-12
RIA SYS. FOR HUMAN GROWTH HORMONE (K780347)Calbiochem-Behring Corp.1978-04-12
WELL TYPE GAMMA COUNTER (K771612)Actus, Inc.1978-04-10
SPECTROPHOTOMETERS (K780342)The Perkin-Elmer Corp.1978-04-10
WELL TYPE GAMMA COUNTER (K771613)Actus, Inc.1978-04-10
NEPHELOMETER (K780251)Kallestad Laboratories, Inc.1978-04-06
CHOLESTEROL RAPID SLAT KIT HDL (K780331)Pierce Chemical Co.1978-04-06
ATOMIZER, FURNACE, GRAPHITE (K780129)The Perkin-Elmer Corp.1978-04-05
DIAGNOSTIC KIT, CPK (K780311)Sclavo, Inc.1978-04-05
CALIBRATORS, CARBON DIOXIDE (K780295)E.I. Dupont DE Nemours & Co., Inc.1978-04-05
DIRECT UREA NITROGEN TEST (K780262)Hycel, Inc.1978-04-05
PREGNANCY TEST KIT, OVER-THE-COUNTER (K780321)Intl. Diagnostic, Inc.1978-04-04
AUTO ISO-FILTER COLLECTION TUBE CAP (K780303)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-03-30
ROCHE TSH RIA (K780428)Hoffmann-La Roche, Inc.1978-03-30
STIKSEP-T4 RIA KIT (K780423)Nuclear Diagnostics, Inc.1978-03-30
HDL CHOLESTEROL METHOD (K780256)Helena Laboratories1978-03-28
REAGENT SYSTEM, ARIA II T3 UPTAKE (K780253)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-03-28
SPECTROPHOTOMETER, FLUORESCENCE M.650-10 (K780242)The Perkin-Elmer Corp.1978-03-27
SPECTROFLUOROMETER SF-330 (K780362)Varian Assoc., Inc.1978-03-22
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