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Clinical Chemistry

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

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RecordFirmDate
ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS (K942549)Alko Diagnostic Corp.1994-07-28
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (K941876)More Diagnostics1994-07-28
OPUS FT4 TEST SYSTEM (K940507)Pb Diagnostic Systems, Inc.1994-07-28
SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (K941698)More Diagnostics1994-07-28
CEDIA T4 MAB ASSAY (K942575)Microgenics Corp.1994-07-28
AVL COMPACT 2 PH/BLOOD GAS ANALYZER (K942616)Avl Scientific Corp.1994-07-28
DNA TRIGLYCERIDE PROCEDURE (K941063)Data Medical Associates, Inc.1994-07-20
ACS CARDIO-TROL CONTROL (K941115)Analytical Control Systems, Inc.1994-07-20
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (K935984)Sigma Diagnostics, Inc.1994-07-20
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE (K941221)Dupont Medical Products1994-07-20
STANBIO ALT/GPT (LUQUI-UV) TEST SET (K941314)Stanbio Laboratory1994-07-20
ABBOTT PRISM ANALYZER (K940289)Abbott Mfg., Inc.1994-07-18
BIOMEK SL WITH BIOMEK SL INCUBATOR (K941498)Beckman Analytical and Biotechnology Development1994-07-14
STANBIO Y-GT (LIQUICOLOR) TEST SET (K941315)Stanbio Laboratory1994-07-14
AIA-PACK TT3 ASSAY (K936229)Tosoh Medics, Inc.1994-07-14
SR1 DHEA-S ENZYME IMMUNOASSAY (K942051)Serono Diagnostics, Inc.1994-07-13
DSL IGFBP-3 RIA (DSL 6700) (K930047)Diagnostic Systems Laboratories, Inc.1994-07-06
PREGNANCY CHECK (K941355)Sa Scientific, Inc.1994-07-06
BODYWISE PREGNANCEY TEST (K941771)Charlton Assoc.1994-07-06
CREATINE KINASE METHOD (K941584)Dupont Medical Products1994-07-06
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT (K934293)Beckman-Diagnostic Systems Group1994-07-06
AXSYM(TM) TOTAL T4 (K934384)Abbott Laboratories1994-06-21
AXSYM TOTAL T3 (K934517)Abbott Laboratories1994-06-21
AXSYM CK-MB (K935924)Abbott Laboratories1994-06-21
AXSYM TOTAL B-HCG (K935673)Abbott Laboratories1994-06-21
AXSYM LUTEINIZING HORMONE (LH) (K935611)Abbott Laboratories1994-06-21
AXSYM FREE THYROXINE ( FREE T4 ) (K934544)Abbott Laboratories1994-06-21
AXSYM ULTRASENSITIVE HTSH (K934410)Abbott Laboratories1994-06-21
AXSYM FOLLICLE STIMULATING HORMONE (FSH) (K935612)Abbott Laboratories1994-06-21
AXSYM(TM) T-UPTAKE (K934312)Abbott Laboratories1994-06-21
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21
N/T PROTEIN CONTROL SY/L, M, AND H (K941912)Behring Diagnostics, Inc.1994-06-16
DSL ESTRONE (DSL 8700) (K935013)Diagnostic Systems Laboratories, Inc.1994-06-16
GLUCOMETER ELITE LOW CONTROL (K940577)Heraeus Kulzer, Inc.1994-06-13
UA PERFECT (K935408)Chimera Research & Chemical, Inc.1994-06-13
ASSURE URINE HCG CONTROL (K941130)Quantimetrix Corp.1994-06-03
DUPONT ACA PLUS PROLACTIN (PROL) METHOD (K941220)Dupont Medical Products1994-06-03
STAT FAX 2600 (K941394)Awareness Technology, Inc.1994-06-03
LIPASE REAGENT SYSTEM (K940457)Medical Diagnostic Technologies, Inc.1994-06-02
APOLIPOPROTIEN B (APO B) (K932603)Sigma Diagnostics, Inc.1994-06-02
UNISTEP HCG PREGNANCY TEST STRIP (K941090)Biotech Atlantic, Inc.1994-06-02
ACCESS PROLACTIN (K941175)Bio-Rad Laboratories, Inc.1994-06-02
APOLIPOPROTIEN A-1 (APO A-1) (K932606)Sigma Diagnostics, Inc.1994-06-02
PREDICTOR HOME PREGNANCY TEST (K940637)Organon Teknika Corp.1994-06-02
ABL5 BLOOD GAS SYSTEM (K935655)Radiometer America, Inc.1994-05-27
ULTRAFREE-CL (K941326)Millipore Corp.1994-05-27
ABL SYSTEM 620 (K935121)Radiometer America, Inc.1994-05-27
SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (K941497)Solarcare, Inc.1994-05-24
AUTO DELFIA (K935047)Wallac OY1994-05-23
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF (K940810)Ciba Corning Diagnostics Corp.1994-05-23
ANI BIOCARD(TM) HCG TEST (K933794)Canadian Bioclinical, Ltd.1994-05-19
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G (K941159)International Technidyne Corp.1994-05-19
LIPASE-PS ASSAY PROCEDURE NO. 805 (K941085)Sigma Diagnostics, Inc.1994-05-17
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET (K941313)Stanbio Laboratory1994-05-17
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 (K941764)Hi Chem, Inc.1994-05-13
CIDBA CORNING ACS CORTISOL IMMUNOASSAY (K934317)Ciba Corning Diagnostics Corp.1994-05-13
I-STAT 200 PORTABLE CLINICAL ANALYZER (K940918)I-Stat Corp.1994-05-10
GLUCOFILM TEST STRIPS (K936212)Heraeus Kulzer, Inc.1994-05-10
URINARY ALBUMIN TEST PACK (K936202)Dupont Medical Products1994-05-09
GLYCATED PROTEIN CALIBRATORS (K940008)Primus Corp.1994-05-09
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (K935014)Diagnostic Systems Laboratories, Inc.1994-05-09
SYNERMED AMYLASE REAGENT KIT (K941091)Synermed, Inc.1994-05-03
LIQUID ALT(SGPT) REAGENT SET (K941287)Pointe Scientific, Inc.,1994-05-03
IMPACT (K940390)Matrix Technologies Corp.1994-05-03
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER (K940058)Sherwood Medical Co.1994-05-02
LIQUID AST (SGOT)REAGENT SET (K941132)Pointe Scientific, Inc.,1994-05-02
BECKMAN DIRECT BILIRUBIN REAGENT (K934068)Beckman-Diagnostic Systems Group1994-04-26
SYNERMED ISE REAGENTS (K941400)Synermed, Inc.1994-04-26
CIBA CORNING ACS FT3 IMMUNOASSAY (K940482)Ciba Corning Diagnostics Corp.1994-04-26
EML 100 (K935120)Radiometer America, Inc.1994-04-26
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR (K934925)Beckman Instruments, Inc.1994-04-26
GLYCATED PROTEIN CONTROLS (K940142)Primus Corp.1994-04-26
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013)Isolab, Inc.1994-04-26
IMMULITE DHEA-S04 (K935806)Diagnostic Products Corp.1994-04-26
CARDIAC T ELISA TROPONIN-T (K924392)Boehringer Mannheim Corp.1994-04-26
MULTICHECK(TM) (K935515)Radiometer America, Inc.1994-04-26
NANOSEP N10 (K935496)Intersep , Ltd.1994-04-26
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP (K935666)The Perkin-Elmer Corp.1994-04-26
SYNERMED IR 500 CHEMISTRY ANALYZER (K935662)Synermed, Inc.1994-04-26
ACCESS CORTISOL REAGENTS (K940221)Bio-Rad Laboratories, Inc.1994-04-26
SYSTEM WASHER 100 (K936258)Eg&G Berthold1994-04-26
TECHNISON AXON SYSTEM (K941156)Miles, Inc.1994-04-26
CEDIA T4 MAB ASSAY (K941042)Microgenics Corp.1994-04-26
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) (K932728)Eastman Kodak Company1994-04-25
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE (K934413)Eastman Kodak Company1994-04-25
SYNERMEDIR CAL I AND SYNERMED IR CAL II (K940571)Synermed, Inc.1994-04-21
SYNERMED TOTAL BILIRUBIN REAGENT KIT (K940570)Synermed, Inc.1994-04-20
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (K940272)Analytical Control Systems, Inc.1994-04-20
VIGIL PRX CHEMISTRY CONTROL (K936184)Beckman-Diagnostic Systems Group1994-04-15
ONE STEP PREGNANCY TEST (K936031)Teco Diagnostics1994-04-15
AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM (K934124)Andronic Devices, Ltd.1994-04-13
BIOSCAN REAGENT STRIPS (K940043)Bioscan Instruments, Inc.1994-04-12
DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS (K933682)Miles, Inc.1994-04-12
JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (K925468)J.J. Skinner, Inc.1994-04-11
KODAK SURECELL HCG URINE TEST, MODIFICATION (K936287)Eastman Kodak Company1994-04-08
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION (K936138)Eastman Kodak Company1994-04-08
RADIAS 3RD GENERATION TSH IMMUNOASSAY (K935119)Bio-Rad1994-04-06
URINARY/CEREBROSPINAL FLUID PROTEIN (K934841)E.I. Dupont DE Nemours & Co., Inc.1994-04-06
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY (K940549)Bio-Rad Laboratories, Inc.1994-04-06
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (K934592)Abaxis, Inc.1994-04-06
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