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Clinical Chemistry

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

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RecordFirmDate
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (K870777)Kone Instruments, Inc.1987-03-13
SHBG IRMA KIT (K861679)Farmos Group , Ltd.1987-03-13
UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE (K864174)United Biotech, Inc.1987-03-13
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT (K870828)Intersect Systems, Inc.1987-03-13
FAST URIC ACID (K870632)Sclavo, Inc.1987-03-13
THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT (K865071)Immuchem Corp.1987-03-13
CO2 REAGENT SET (K864313)Hf Scientific, Inc.1987-03-13
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT (K870827)Intersect Systems, Inc.1987-03-13
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS (K870106)Diagnostic Products Corp.1987-03-13
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT (K870776)Reagents Applications, Inc.1987-03-13
FAST GLUCOSE (K870631)Sclavo, Inc.1987-03-13
BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438)Beckman Instruments, Inc.1987-03-12
APO B., IMMUNOTURBIDIMETRIC ASSAY (K864228)Intl. Diagnostic Laboratories, Ltd.1987-03-12
AFFINITY(TM) HTSH IMMUNIT(TM) (K865081)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
TOTAL/IGE THEOPHYLLINE CONTROL SERA (K870151)3M Company1987-03-12
IQ FREE T4 IMMUNOASSAY (K864658)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
AFFINITY(TM) SYSTEM (K865105)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
DIMENSION-WBG (K863223)Dimension Diagnostics1987-03-10
VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (K870259)Leeco Diagnostics, Inc.1987-03-10
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY (K870520)Hybritech, Inc.1987-03-10
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 (K870462)Em Diagnostic Systems, Inc.1987-03-10
TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY (K865057)Hybritech, Inc.1987-03-10
WAKO(TM) AUTOKIT LDH (K870401)Wako Chemicals USA, Inc.1987-03-06
SUPER URINE ANALYZER SYSTEM (K870526)Kyoto Daiichi Kagaku Co., Ltd.1987-03-06
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 (K870461)Em Diagnostic Systems, Inc.1987-03-06
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM (K865036)Ciba Corning Diagnostics Corp.1987-03-06
ALANINE AMINOTRANSFERASE (ALT)/(GPT) (K870086)Catachem, Inc.1987-03-06
ASPARTATE AMINOTRANSFERASE (AST)/(GOT) (K870077)Catachem, Inc.1987-03-06
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 (K870170)Em Diagnostic Systems, Inc.1987-03-06
GLUCOSE OXIDASE REAGENT (K870616)Intersect Systems, Inc.1987-03-06
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX (K870553)Em Diagnostic Systems, Inc.1987-03-06
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST (K870500)American Diagnostic Corp.1987-03-06
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 (K870408)Em Diagnostic Systems, Inc.1987-03-04
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 (K870571)Em Diagnostic Systems, Inc.1987-03-04
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 (K870407)Em Diagnostic Systems, Inc.1987-03-04
ISE COMPENSATION SERA (K870379)Boehringer Mannheim Corp.1987-02-26
MPX SYSTEM, GLUCOSE TEST SYSTEM (K864322)Lifescan, Inc.1987-02-25
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT (K864855)Amersham Corp.1987-02-25
SMI DIGITRON (K870406)American Dade1987-02-25
710 PLUS (K864557)Ciba Corning Diagnostics Corp.1987-02-25
IRON(IRN) TESTPACK, ITEM NO. 67659/95 (K870144)Em Diagnostic Systems, Inc.1987-02-20
OLYMPUS PK300 (K864834)Olympus Corp.1987-02-20
TRIGLYCERIDE (GPO-TRINDER) REAGENT (K870012)Sigma Diagnostics, Inc.1987-02-20
REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. (K864862)Hf Scientific, Inc.1987-02-20
AMYLASE COLORIMETRIC PROCEDURE (K864825)Data Medical Associates, Inc.1987-02-20
DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET (K870252)Casco Standards1987-02-20
SIMULTRAC FREE T4[57CO]/TSH MAB[125I] (K864838)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-18
REFLOTRON(R) AST (GOT) (K870246)Boehringer Mannheim Corp.1987-02-18
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (K864530)Miles Laboratories, Inc.1987-02-18
BICARBONATE PROCEDURE (K870062)Data Medical Associates, Inc.1987-02-13
WAKO (TM) AUTOKIT GOT TEST (K864813)Wako Chemicals USA, Inc.1987-02-13
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR (K864909)E.I. Dupont DE Nemours & Co., Inc.1987-02-13
ELECTRA AUTOMATIC SAMPLER (K864875)Medical Laboratory Automation Systems, Inc.1987-02-13
RAICHEM (TM)SERUM IRON AND TIBC REAGENTS (K864819)Reagents Applications, Inc.1987-02-12
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC) (K864992)Reagents Applications, Inc.1987-02-12
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 (K870143)Em Diagnostic Systems, Inc.1987-02-11
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST (K865076)Syntron Bioresearch, Inc.1987-02-11
UV VISIBLE SPECTROPHOTOMETERS (K864451)Trans-National Trade Development Corp.1987-02-06
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) (K864359)Trace Scientific , Ltd.1987-02-06
DPC COAT-A-COUNT IRMA LH KIT (K863934)Diagnostic Products Corp.1987-02-06
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K864357)Trace Scientific , Ltd.1987-02-06
ARTEL DIFFERENTIAL PHOTOMETER (K864542)Artel, Inc.1987-02-06
UNIFAST CALCIUM TEST (K864661)Sclavo, Inc.1987-02-04
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL (K864445)Nova Biomedical Corp.1987-02-04
HCG SOLID PHASE COMPONENT SYSTEM (K864591)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-04
ADX(TM) ANALYZER (K864566)Abbott Laboratories1987-02-04
BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH (K864659)Bio Mega Diagnostic, Inc.1987-02-04
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE (K864522)Beckman Instruments, Inc.1987-02-04
TSH MAB IRMA (K864839)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-02-04
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE (K863442)United Biotech, Inc.1987-02-04
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT (K864452)Lkb Instruments, Inc.1987-02-02
ALFERR TIBC TUBE (K864548)Benchmark Reagents1987-02-02
BECKMAN EPSILON(TM) PROLACTIN TEST KIT (K864439)Beckman Instruments, Inc.1987-01-21
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882)Pointe Scientific, Inc.,1987-01-21
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 (K870033)American Research Products Co.1987-01-21
PSI AMYLASE REAGENT (K864464)Pointe Scientific, Inc.,1987-01-21
AMYLASE REAGENT (K864356)Trace Scientific , Ltd.1987-01-21
APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC (K864393)Intl. Diagnostic Laboratories, Ltd.1987-01-16
BAYER HEALTHCARE RAPIDQC PLUS (K870036)Ciba Corning Diagnostics Corp.1987-01-14
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (K862483)Pantex, Div. Bio-Analysis, Inc.1987-01-14
CARDS(TM) - EARLY PREGNANCY TEST (K863341)Pacific Biotech, Inc.1987-01-14
LAD MODEL 535 LUMINOMETER (K864201)Los Alamos Diagnostics1987-01-13
CREATINE PHOSPHOKINASE (CK) (K864744)Tech-Co, Inc.1987-01-13
ALKALINE PHOSPHATASE (K864905)Tech-Co, Inc.1987-01-13
AST S.C.E. (GOT) (K863054)J. D. Assoc.1987-01-13
CHEMTROL(TM) (K862565)G.B.F. Industries, Inc.1987-01-13
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403) (K864863)Dynatech Laboratories, Inc.1987-01-13
UREA NITROGEN(BUN), COLORIMETRIC METHOD (K864742)Tech-Co, Inc.1987-01-13
PEG 6,000 (K863103)J. D. Assoc.1987-01-13
BIURET (COLORIMETRIC), TOTAL PROTEIN (K864743)Tech-Co, Inc.1987-01-13
OHMEDA 6000 MULTI-GAS MONITOR (K863959)Ohmeda Medical1987-01-12
SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) (K864267)Millipore Corp.1987-01-09
GENERAL PURPOSE CENTRIFUGE (K864974)Norfolk Scientific, Inc.1987-01-09
TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (K861202)Nms Pharmaceuticals, Inc.1987-01-09
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K864741)Tech-Co, Inc.1987-01-09
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966)Diagnostics Biochem Canada, Inc.1987-01-09
VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (K863999)Leeco Diagnostics, Inc.1987-01-09
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) (K864373)Unipath , Ltd.1987-01-09
WAKO(TM) AUTOKIT GPT (K864850)Wako Chemicals USA, Inc.1987-01-09
TERUMO OVATION SPECTROPHOTOMETER (K864285)Terumo Medical Corp.1987-01-09
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