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Clinical Chemistry

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

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RecordFirmDate
BUN (LIQUID) REAGENT SET (K972671)Pointe Scientific, Inc.,1997-07-20
AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K972297)Trace America, Inc.1997-07-17
CREATINE KINASE (CK) (K972155)Stanbio Laboratory1997-07-17
CREATINE KINASE-MB REAGENT SET (K971566)Horizon Diagnostics, Inc.1997-07-14
DADE TRU-LIQUID BILIRUBIN CONTROL (K972287)Dade Intl., Inc.1997-07-07
MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420)Pharmacia, Inc.1997-06-30
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103)Tosoh Medics, Inc.1997-06-27
SYNERMED IR 200 CHEMISTRY ANALYZER (K971491)Synermed, Inc.1997-06-26
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS (K972070)Nichols Institute Diagnostics1997-06-26
THYROTROPIN(TSH) ELISA (K971780)Monobind1997-06-24
ABBOTT AXSYM FOLATE (K972232)Abbott Laboratories1997-06-24
TOTAL BILIRUBIN REAGENT (K972073)Carolina Liquid Chemistries Corp.1997-06-24
PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921)Monobind1997-06-24
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) (K972214)Roche Diagnostic Systems, Inc.1997-06-24
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133)Johnson & Johnson Clinical Diagnostics, Inc.1997-06-24
CALCIUM REAGENT (K971907)Carolina Liquid Chemistries Corp.1997-06-24
ELECT II BLOOD GLUCOSE MONITORING SYSTEM (K970707)Selfcare, Inc.1997-06-20
TRIGLYCERIDES, TG, OR TRIG (K971324)Carolina Liquid Chemistries Corp.1997-06-20
CHOLESTEROL REAGENT (K971072)Derma Media Lab., Inc.1997-06-20
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET (K971573)Genzyme Corp.1997-06-18
OPUS PROGESTERONE (K971725)Behring Diagnostics, Inc.1997-06-18
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3 (K972080)Consolidated Technologies, Inc.1997-06-18
CREA OR CREATININE (K971908)Carolina Liquid Chemistries Corp.1997-06-17
BUN (K971967)Carolina Liquid Chemistries Corp.1997-06-17
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (K971449)Becton Dickinson Vacutainer Systems1997-06-17
TOTAL THROXINE MICROPLATE EIA(225-300) (K971709)Monobind1997-06-16
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS (K972004)Alko Diagnostic Corp.1997-06-16
ELECSYS CEA ASSAY (K964368)Boehringer Mannheim Corp.1997-06-16
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR (K971162)Genzyme Corp.1997-06-16
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) (K971952)Bio-Rad1997-06-16
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (K971467)Carolina Liquid Chemistries Corp.1997-06-16
ACTIVE TESTOSTERONE EIA (DSL-10-4000) (K971823)Diagnostic Systems Laboratories, Inc.1997-06-16
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER (K971276)Bayer Corp.1997-06-16
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER (K971111)Tri-Tech, Inc.1997-06-16
SPECIALITY URINE 1,2 (K971405)Chiron Diagnostics Corp.1997-06-16
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (K971779)Monobind1997-06-16
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K971190)Genzyme Corp.1997-06-16
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT (K971902)Roche Diagnostic Systems, Inc.1997-06-16
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT (K971505)Beckman Instruments, Inc.1997-06-11
ACCUTEST HCG-URINE (K971886)Unotech Diagnostics, Inc.1997-06-11
OLYMPUS CK-MB REAGENT (K971817)Olympus America, Inc.1997-06-11
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) (K971954)Bio-Rad1997-06-11
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K970735)Randox Laboratories, Ltd.1997-06-06
ACS ESTADIOL-6 II (K970386)Chiron Diagnostics Corp.1997-06-04
PARAMAX CHOLESTEROL REAGENT (K964660)Dade Intl., Inc.1997-06-04
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS (K963018)Bio-Rad1997-06-04
GREINER VACUETTE BLOOD COLLECTION TUBE (K971220)Greiner America, Inc.1997-06-04
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (K970905)Beckman Instruments, Inc.1997-06-04
SYNCHRON SYSTEMS CAL 5 PLUS (K971283)Beckman Instruments, Inc.1997-06-03
CK REAGENT (K971396)Carolina Liquid Chemistries Corp.1997-05-29
DMA TRIGLYCERIDES PROCEDURES (K971113)Data Medical Associates, Inc.1997-05-29
CHOL OR CHOLESTEROL (K971345)Carolina Liquid Chemistries Corp.1997-05-29
IMMULITE PYRILINKS-D (K971312)Diagnostic Products Corp.1997-05-27
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K971477)Trace America, Inc.1997-05-27
QUANTEX ASO-CRP-RF CONTROL (K971777)Instrumentation Laboratory CO1997-05-27
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K971485)Trace America, Inc.1997-05-27
AUTO HDL CHOLESTEROL CALIBRATOR (K970933)Pointe Scientific, Inc.,1997-05-23
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD (K971333)Beckman Instruments, Inc.1997-05-23
DSL ACTIVE T3 EIA (K971270)Diagnostic Systems Laboratories, Inc.1997-05-22
DSL ACTIVE T4 EIA (K971269)Diagnostic Systems Laboratories, Inc.1997-05-22
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (K964635)Nichols Institute Diagnostics1997-05-21
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT (K970919)Beckman Instruments, Inc.1997-05-21
ROCHE COBAS AMPLICOR ANALYZER (K964506)Roche Molecular Systems, Inc.1997-05-21
ACE HDL-C REAGENT (K971526)Schiapparelli Biosystems, Inc.1997-05-21
SYNCHRON SYSTEMS THYROXINE REAGENT (K971203)Beckman Instruments, Inc.1997-05-16
IMMULITE VITAMIN B12 (LKVB1,LKVB5) (K971177)Diagnostic Products Corp.1997-05-16
ALP REAGENT SET (K971463)Carolina Liquid Chemistries Corp.1997-05-16
DSL ESTRONE-SULFATE RIA (K970915)Diagnostic Systems Laboratories, Inc.1997-05-16
TOTAL PROTEIN OR TP (K971524)Carolina Liquid Chemistries Corp.1997-05-16
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM (K970556)Lifescan, Inc.1997-05-12
GREINER VACUETTE BLOOD COLLECTION TUBE (K971239)Greiner America, Inc.1997-05-12
DSL ACTIVE NON-EXTRACTION IGF-I ELISA (K971353)Diagnostic Systems Laboratories, Inc.1997-05-12
GREINER VACUETTE BLOOD COLLECTION TUBE (K971236)Greiner America, Inc.1997-05-12
STAT PROFILE ULTRA M ANALYZER (K970710)Nova Biomedical Corp.1997-05-09
WINMAX SOFTWARE SYSTEMS (K965103)Diagnostic Products Corp.1997-05-09
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST (K971286)Excel Scientific, Inc.1997-05-08
LACTATE DEHYDROGENASE (LD) (K970684)Randox Laboratories, Ltd.1997-05-07
WAKO DIRECT BILIRUBIN V (K970986)Wako Chemicals USA, Inc.1997-05-07
SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (K971466)Carolina Liquid Chemistries Corp.1997-05-06
LD-L REAGENT (K971398)Carolina Liquid Chemistries Corp.1997-05-02
GREINER VACUETTE BLOOD COLLECTION TUBE (K971221)Greiner America, Inc.1997-05-02
ALB OR ALBUMIN (K971445)Carolina Liquid Chemistries Corp.1997-05-02
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (K971141)Dade Chemistry Systems, Inc.1997-04-28
ACCULINE PREGNANCY TEST (K971122)Genix Biotek, Inc.1997-04-25
LIQUID LIGAND 1,2,3 (K971071)Chiron Diagnostics Corp.1997-04-23
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS (K971014)Lifescan, Inc.1997-04-23
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT (K964756)Wano-Tech Corp.1997-04-23
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (K970314)Beckman Instruments, Inc.1997-04-21
WAKO TOTAL BILIRUBIN V (K970985)Wako Chemicals USA, Inc.1997-04-21
MINI SAMPLER PROCESSOR (K970616)Cavro Scientific Instruments, Inc.1997-04-21
URIC ACID REAGENT (K970867)Derma Media Lab., Inc.1997-04-21
LIQUID GLUCOSE (OXIDASE) REAGENT SET (K970781)Pointe Scientific, Inc.,1997-04-21
ALT OR SGPT (K971323)Carolina Liquid Chemistries Corp.1997-04-21
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT (K971363)Carolina Liquid Chemistries Corp.1997-04-21
TRIGLYCERIDES (K971005)Derma Media Lab., Inc.1997-04-21
AST OR SGOT (K971344)Carolina Liquid Chemistries Corp.1997-04-21
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (K970778)More Diagnostics1997-04-17
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (K965035)Beckman Instruments, Inc.1997-04-17
URIC, UA, OR URIC ACID (K971133)Carolina Liquid Chemistries Corp.1997-04-14
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (K970330)Dade Intl., Inc.1997-04-14
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