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Clinical Chemistry

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

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RecordFirmDate
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) (K880496)Bio-Rad1988-03-16
GLUCOSE HEXOKINASE (K880236)Tech-Neal Scientific, Inc.1988-03-15
CO2 REAGENT (K880268)Sigma Diagnostics, Inc.1988-03-15
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU. (K880395)Data Medical Associates, Inc.1988-03-15
EASY-TEST LACTIC ACID (LA) (K880787)Diagnostic Systems1988-03-15
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) (K880495)Bio-Rad1988-03-15
CONCEP-7-BHCG (K880577)Leeco Diagnostics, Inc.1988-03-15
TRIGLYCERIDE (K880238)Tech-Neal Scientific, Inc.1988-03-15
ION TRAP DETECTOR (K880090)Finnigan Corp.1988-03-15
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. (K880397)Data Medical Associates, Inc.1988-03-15
ALKALINE PHOSPHATASE REAGENT SET (K880307)Tech-Neal Scientific, Inc.1988-03-15
HCG-NOSTICK (K880328)Organon Teknika Corp.1988-03-15
TRIGLYCERIDES (GPO-TRINDER) (K880628)Tech-Co, Inc.1988-03-15
KONE CALCIUM TEST (K880242)The Rupp & Bowman Co.1988-03-15
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU. (K880396)Data Medical Associates, Inc.1988-03-15
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) (K880494)Bio-Rad1988-03-03
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (K880388)Serono Diagnostics, Inc.1988-03-03
GLUCOSE (HEXOKINASE) (K874846)Tech-Co, Inc.1988-03-03
CIBA CORNING MODEL 644 (K875098)Ciba Corning Diagnostics Corp.1988-03-03
AST (SGOT) REAGENT SET (K880276)Tech-Neal Scientific, Inc.1988-03-03
ALT (SGPT) REAGENT SET (K880275)Tech-Neal Scientific, Inc.1988-03-01
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL (K880175)Baxter Healthcare Corp1988-03-01
WAKO(TM) AUTOKIT CHOLESTEROL (K880311)Wako Chemicals USA, Inc.1988-03-01
IQ ALKALINE PHOSPHATASE (K880344)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-03-01
(SKD) CHOLESTEROL TEST KIT (K875131)Smithkline Diagnostics, Inc.1988-03-01
BINAX PROLACTIN IRMA DIAGNOSTIC KIT (K880218)Binax, Inc.1988-03-01
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339)Em Diagnostic Systems, Inc.1988-02-25
AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 (K880039)Sigma Diagnostics, Inc.1988-02-24
KODAK EKTACHEM DT SLIDES (LIPA) (K875173)Eastman Kodak Company1988-02-24
KODAK EKTACHEM DT SLIDES (CRSC) (K875191)Eastman Kodak Company1988-02-24
KODAK EKTACHEM DT SLIDES (CKMB) (K875192)Eastman Kodak Company1988-02-24
BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (K875248)Bioscan Instruments, Inc.1988-02-24
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 (K874362)Amersham Corp.1988-02-18
MULTI-ENZYME LINEARITY SOLUTION (K880266)Verichem Laboratories, Inc.1988-02-18
DSL ACTIVE ESTRADIOL RIA (DSL #4300) (K873550)Diagnostic Systems Laboratories, Inc.1988-02-18
ASPARTATE AMINOTRANSFERASE AST/SGOT (K875071)Tech-Co, Inc.1988-02-18
CREATINE KINASE (COLORIMETRIC METHOD) (K880178)Tech-Co, Inc.1988-02-18
LYPHOCHEK WHOLE BLOOD CONTROL (K874731)Bio-Rad1988-02-18
HDL CHOLESTEROL PRECIPITATING REAGENT (K880176)Tech-Co, Inc.1988-02-18
QM300 CALIBRATOR B PACK (K875282)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-17
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 (K874623)Cyberfluor, Inc.1988-02-16
TECHNICON SMAC 3 SYSTEM (K875105)Technicon Instruments Corp.1988-02-16
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT (K874782)Diagnostic Products Corp.1988-02-11
IRON PROCEDURE (K874918)Data Medical Associates, Inc.1988-02-11
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (K874866)Serono Diagnostics, Inc.1988-02-11
UREA NITROGEN (BUN) (K880078)Tech-Neal Scientific, Inc.1988-02-11
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL (K874832)Nova Biomedical Corp.1988-02-11
FINNIGAN MAT TSQ-70 (K880089)Finnigan Corp.1988-02-11
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (K874903)Simmler, Inc.1988-02-11
IMMPULSE T4 ASSAY REAGENTS (K875081)Sclavo, Inc.1988-02-11
CALCIUM ASSAY KIT, NUMBER 120-19 (K874496)Diagnostic Chemicals, Ltd. (Usa)1988-02-11
LEECO PREGNASTICK (EIA) CATALOG #003 (K880069)Leeco Diagnostics, Inc.1988-02-11
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0 (K874857)Eastman Kodak Company1988-02-08
KODAK SURECELL(TM) HCG-URINE KIT (K874388)Eastman Kodak Company1988-02-08
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) (K875263)Technicon Instruments Corp.1988-02-08
BIOTROL CALIBRANT LEVEL 2 (K875304)Biotrol, USA, Inc.1988-02-03
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM (K870708)Kyoto Daiichi Kagaku Co., Ltd.1988-02-02
BIOTROL CALIBRANT LEVEL 3 (K875318)Biotrol, USA, Inc.1988-02-02
BETA-HCG ASSAY (K873986)Schiff & Co.1988-02-02
V-TREND BETA-HCG DRY-SPOT TEST (K875262)Texas Immunology, Inc.1988-02-02
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 (K875210)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
BIOTROL CALIBRANT LEVEL 1 (K875288)Biotrol, USA, Inc.1988-02-02
WAKO(TM) UIBC (K875176)Wako Chemicals USA, Inc.1988-02-02
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 (K875206)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL (K874302)Quantimetrix Medical Industries1988-02-02
MODIFIED CALCITONIN RIA KIT DSL #1200 (K874087)Diagnostic Systems Laboratories, Inc.1988-02-02
OVEIA (TM) DUAL ANALYTE (K872843)Boots-Celltech Diagnostics, Inc.1988-02-02
ACID PHOSPHATASE (KINETIC) CAT. # 320-06 (K875209)Diagnostic Chemicals, Ltd. (Usa)1988-02-01
BIOTROL URIC ACID ENZYMATIQUE UV H.P. (K875320)Biotrol, USA, Inc.1988-02-01
ACID PHOSPHATASE TEST (K873726)King Diagnostics, Inc.1988-01-27
TOTAL PROTEIN (K875222)Catachem, Inc.1988-01-22
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R) (K874506)Technicon Instruments Corp.1988-01-22
PYRIDOXAL-5-PHOSPHATE TABLETS (K874835)Boehringer Mannheim Corp.1988-01-21
KODAK EKTACHEM DT SLIDES (PHOS) (K874577)Eastman Kodak Company1988-01-21
A-GENT TRIGLLYCERIDES GPO (K874187)Abbott Laboratories1988-01-21
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K874824)Supelco, Inc.1988-01-21
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 (K874586)Em Diagnostic Systems, Inc.1988-01-21
WAKO(TM) PRETEST 5A (K873366)Wako Chemicals USA, Inc.1988-01-21
MULTICHEM (R) MAGNESIUM REAGENT (K874595)Simmler, Inc.1988-01-21
TRIGLYERIDES TEST KIT (K874584)Ciba Corning Diagnostics Corp.1988-01-21
RAICHEM(TM) MAGNESIUM REAGENT (K874822)Reagents Applications, Inc.1988-01-21
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM (K874284)Diagnostic Chemicals, Ltd. (Usa)1988-01-21
V-TREND BETA-HCG TEST (K874638)Texas Immunology, Inc.1988-01-21
KODAK EKTACHEM DT SLIDES (MG) (K874576)Eastman Kodak Company1988-01-21
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II (K874280)Bio-Rad1988-01-21
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 (K874600)Em Diagnostic Systems, Inc.1988-01-21
QUANTIMETRIX URINE DIPSTICK CONTROL (K874890)Quantimetrix Medical Industries1988-01-21
BILIRUBIN (TOTAL) (K875069)Tech-Co, Inc.1988-01-11
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301 (K874624)Cyberfluor, Inc.1988-01-11
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 (K874621)Cyberfluor, Inc.1988-01-11
ALBUMIN, BROMCRESOL GREEN DYE-BINDING (K875070)Tech-Co, Inc.1988-01-11
MULTICHEM HDL PRECIPITATING REAGENT #S0914 (K874820)Simmler, Inc.1988-01-07
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM (K874809)Biotrol, USA, Inc.1988-01-07
REFLOTRON (R) AMYLASE (K874704)Boehringer Mannheim Corp.1988-01-05
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (K873371)Bio-Rad1988-01-05
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM (K874810)Biotrol, USA, Inc.1988-01-05
DC-TROL LEVEL 1 OR 2 (K874772)Diagnostic Chemicals, Ltd. (Usa)1988-01-05
LUMICON (K873893)Hamilton Co.1988-01-05
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X (K874033)Diagnostic Products Corp.1988-01-05
PARAMAX URINE/CSF CALIBRATOR (K874587)Baxter Healthcare Corp1988-01-05
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