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Clinical Chemistry

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

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RecordFirmDate
LYTENING 5 (K880917)Amdev, Inc.1988-05-27
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P. (K881702)Biotrol, USA, Inc.1988-05-27
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 (K881229)Em Diagnostic Systems, Inc.1988-05-27
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC (K880880)Reagents Applications, Inc.1988-05-27
QUIDEL PREGNANCY TEST (K881595)Quidel Corp.1988-05-27
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II (K881258)Baxter Healthcare Corp1988-05-27
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (K881005)Icn Biomedicals, Inc.1988-05-27
EMIT CONVENIENCE PACK: THYROXINE ASSAY (K881357)Syva Co.1988-05-27
LIQUID CHROMATO. COLUMNS (K880724)Supelco, Inc.1988-05-27
LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (K881443)London Diagnostics, Inc.1988-05-27
LIPASE UV [TOYO] (K874027)Advocacy International, Ltd.1988-05-27
TOTAL BILIRUBIN REAGENT (K881241)Tech-Neal Scientific, Inc.1988-05-27
HDL CHOLESTEROL PRECIPITATING PROCEDURE (K881326)Data Medical Associates, Inc.1988-05-27
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057 (K881596)Medix Biotech, Inc.1988-05-27
CALCIUM (K880308)Catachem, Inc.1988-05-27
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) (K880692)Diagnostic Chemicals, Ltd. (Usa)1988-05-27
MULTI-FUNCTION BLOOD GAS CONTROL (K880447)Bionostics, Inc.1988-05-27
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT (K881373)Amersham Corp.1988-05-27
WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER (K863395)Wescor, Inc.1988-05-24
PREGNANCY (HCG) CARD & LIQUID TEST (K880163)Ampcor, Inc.1988-05-17
MAGNESIUM LIQUID STABLE REAGENT SET (K881300)Medical Analysis Systems, Inc.1988-05-17
ADVANCE* AND DAISY* PREGNANCY TEST (K880472)Advanced Care Products1988-05-16
HR VACUTRAC (K881201)Icu Medical, Inc.1988-05-16
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA (K881255)Nova Biomedical Corp.1988-05-16
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II (K881275)Fisher Scientific Co., LLC1988-05-16
BIOTROL CK MONOEACTIF (K881267)Biotrol, USA, Inc.1988-05-16
BIOTROL BUN ENZYMATIQUE UV H.P. (K881366)Biotrol, USA, Inc.1988-05-16
VACUGUARD(TM) (K880594)Habley Medical Technology Corp.1988-04-28
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK (K873577)Diamond Sensor Systems1988-04-28
DIRECT BILIRUBIN PROCEDURE (K881166)Data Medical Associates, Inc.1988-04-28
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO. (K881123)Nichols Institute Diagnostics1988-04-28
MICRO-BUMINTEST REAGENT TABLETS (K874909)Miles Laboratories, Inc.1988-04-28
CARBON DIOXIDE REAGENT (K881169)Intersect Systems, Inc.1988-04-28
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K881311)Biotrol, USA, Inc.1988-04-28
PREGNANCY BETA-HCG CARD & LIQUID TEST (K880478)Ampcor, Inc.1988-04-28
ACP KINETIC TEST (ACID PHOSPHATASE TEST) (K881204)Sclavo, Inc.1988-04-28
CHLORIDE LIQUID STABLE REAGENT SET (K881200)Medical Analysis Systems, Inc.1988-04-28
CREATINE KINASE (CK) REAGENT SET (K881237)Tech-Neal Scientific, Inc.1988-04-28
CHLORIDE REAGENT SET (K881240)Tech-Neal Scientific, Inc.1988-04-28
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS (K881400)Catachem, Inc.1988-04-28
PARAMAX IRON REAGENT (K881104)Baxter Healthcare Corp1988-04-28
IRON TEST (K881202)Sclavo, Inc.1988-04-28
PHOSPHORUS (INORGANIC) (K881171)Tech-Co, Inc.1988-04-28
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 (K880866)Diagnostic Chemicals, Ltd. (Usa)1988-04-28
MICRO CO2 APPARATUS (K880967)Hf Scientific, Inc.1988-04-28
IRON PROCEDURE (K881167)Data Medical Associates, Inc.1988-04-28
CHOLESTEROL (K880237)Tech-Neal Scientific, Inc.1988-04-28
HEART CHECK APOLIPOPROTEIN-B (K881433)Northwest Biotech1988-04-21
HEART CHECK APOLIPOPROTEIN A-1 (K881434)Northwest Biotech1988-04-21
AMYLASE 405 CATALOG NUMBER 301-34 (K880867)Diagnostic Chemicals, Ltd. (Usa)1988-04-19
ABBOTT IMX T3 (K880087)Abbott Laboratories1988-04-18
CALCIUM, CATALOGUE NUMBER 122-20 (K881054)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
LABCO LIMITED EXETAINER(R) (K880622)Labco, Ltd.1988-04-18
ALKALINE PHOSPHATASE REAGENT, DEA BUFF (K880796)Trace America, Inc.1988-04-18
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY (K881124)Nichols Institute Diagnostics1988-04-18
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF. (K880795)Trace America, Inc.1988-04-18
ALBUMIN CAT. # 201-03 (K875207)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
ACID PHOSPHATASE REAGENT (K880798)Trace America, Inc.1988-04-18
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO (K880619)Syva Co.1988-04-18
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT (K880934)Amersham Corp.1988-04-18
GLUCOSE (TRINDER) CAT. # 220-32 (K875211)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (K880758)Boots-Celltech Diagnostics, Inc.1988-04-18
URIC ACID REAGENT SET (K880277)Tech-Neal Scientific, Inc.1988-04-18
DEXPAD, BLOOD GLUCOSE STRIP (K880585)Mach Diag. C/O Wichita State University1988-04-18
CHLORIDE CAT. # 152-17 (K875208)Diagnostic Chemicals, Ltd. (Usa)1988-04-18
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL (K880794)Trace America, Inc.1988-04-18
ROMEO(TM) MODEL 1000 (K872889)Diva Medical Systems, Inc.1988-04-13
ALBUMIN REAGENT SET (K880844)Tech-Neal Scientific, Inc.1988-04-05
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT (K880743)Abbott Laboratories1988-04-05
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY (K880678)Ventrex Laboratories, Inc.1988-04-05
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT (K880410)Disease Detection International, Inc.1988-04-05
CREATININE REAGENT SET (KINETIC) (K880843)Tech-Neal Scientific, Inc.1988-04-05
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER (K880949)Advanced Biomedical Methods, Inc.1988-04-05
ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT (K880177)Tech-Co, Inc.1988-04-05
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (K875079)Miles Laboratories, Inc.1988-04-05
FIRST RESPONSE 5 MINUTE PREGNANCY TEST (K874823)Tambrands, Inc.1988-04-05
LDH-L REAGENT SET (K880842)Tech-Neal Scientific, Inc.1988-04-05
CALCIUM REAGENT SET (K880845)Tech-Neal Scientific, Inc.1988-04-05
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01 (K881254)Norfolk Scientific, Inc.1988-04-05
ABBOTT IMX HTSH (K880086)Abbott Laboratories1988-04-05
ABBOTT IMX HCG (K880070)Abbott Laboratories1988-03-24
TOTAL IRON BINDING CAPACITY (TIBC) (K880546)Boehringer Mannheim Corp.1988-03-24
WAKO(TM) AUTOKIT TOTAL PROTEIN (K880312)Wako Chemicals USA, Inc.1988-03-24
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT (K880687)Amersham Corp.1988-03-24
UNIMETER CALIBRATION KIT (K880610)Boehringer Mannheim Corp.1988-03-24
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (K874875)Boots-Celltech Diagnostics, Inc.1988-03-24
WAKO(TM) AUTOKIT ALBUMIN (K880313)Wako Chemicals USA, Inc.1988-03-24
PROTEIN BASE ISE CONTROL (K880710)Bionostics, Inc.1988-03-24
WAKO AUTOKIT URIC ACID (K880731)Wako Chemicals USA, Inc.1988-03-24
INORGANIC PHOSPHORUS REAGENT SET (K880676)Tech-Neal Scientific, Inc.1988-03-24
EMIT THYROXINE ASSAY (K880620)Syva Co.1988-03-24
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR (K880467)Stanbio Laboratory1988-03-24
QUANTIMETRIX SERUM ENZYME CONTROL (K880701)Quantimetrix Corp.1988-03-24
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY (K880296)London Diagnostics, Inc.1988-03-24
TOTAL PROTEIN REAGENT SET (K880677)Tech-Neal Scientific, Inc.1988-03-24
PARAMAX AMMONIA REAGENT (K880651)Baxter Healthcare Corp1988-03-24
CREATININE (K880629)Tech-Co, Inc.1988-03-23
LACTATE DEHYDROGENASE (LDH-L) (K880630)Tech-Co, Inc.1988-03-16
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) (K880609)Technicon Instruments Corp.1988-03-16
VISION(R) THYROXINE (T4) (K880662)Abbott Laboratories1988-03-16
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