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Clinical Chemistry

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

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RecordFirmDate
ACTH IRMA KIT MITSUBISHI YUKA (K910178)Science Regulatory Services Intl.1991-05-22
HDL CHOLESTEROL REAGENT (K911406)Genzyme Corp.1991-05-22
OSMOMETER MODEL 2400 (K911092)Advanced Instruments, Inc.1991-05-22
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE (K911755)Bionostics, Inc.1991-05-22
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION (K911578)Cholestech Corp.1991-05-15
STRATUS(R) AUTOMATED SAMPLE HANDLER (K911712)Baxter Healthcare Corp1991-05-15
VISION BG MONITOR (K911596)British-American Medical, Inc.1991-05-15
FIRST CHOICE(TM), MODIFICATION (K911792)Polymer Technology Corp.1991-05-15
TOTAL BILIRUBIN REAGENT SET (K910635)Biochemical Trade, Inc.1991-05-15
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED (K911803)Hichem Diagnostics1991-05-15
CLEARVIEW HCG SERUM/URINE (K905741)Unipath , Ltd.1991-05-15
SUPERSERUM REAGENT (SSR) (K910646)International Technidyne Corp.1991-05-10
DOCUMENT REFLECTANCE II LINEARITY TEST SET (K910440)Casco Standards1991-05-10
SYSTEMATE CREATININE (EPOS APPLICATION) #65413 (K905658)Em Diagnostic Systems, Inc.1991-05-08
HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER (K911141)Hemocue, Inc.1991-05-08
ROCHE REAGENT FOR APOLIPOPROTEIN B (K910552)Roche Diagnostic Systems, Inc.1991-05-07
ROCHE REAGENT FOR APOLIPOPROTEIN A-1 (K910551)Roche Diagnostic Systems, Inc.1991-05-07
CLEARBLUE EASY (K911566)Unipath , Ltd.1991-05-06
BIOTROL PROTEIN MULTILEVEL STANDARDS (K910721)Biotrol, USA, Inc.1991-05-06
SRI T3 IMMOENZYMETRIC ASSAY (K910737)Serono-Baker Diagnostics, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III (K911178)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I (K911169)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III (K911171)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II (K911177)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I (K911176)Analytical Control Systems, Inc.1991-05-01
CIBA CORNING ACS FT4 IMMUNOASSAY (K910684)Ciba Corning Diagnostics Corp.1991-05-01
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II (K911170)Analytical Control Systems, Inc.1991-05-01
AMYLASE (K910158)Pointe Scientific, Inc.,1991-04-30
CIBA CORNING ACS TSH IMMUNOASSAY (K910981)Ciba Corning Diagnostics Corp.1991-04-30
J&S PEDIATRIC IRON SATURATING REAGENT (K910672)J.S. Medical Assoc.1991-04-29
IMMULITE(TM) T-UPTAKE (K910677)Cirrus Diagnostics, Inc.1991-04-29
CIBA CORNING ACS T UPTAKE IMMUNOASSAY (K911093)Ciba Corning Diagnostics Corp.1991-04-29
ROCHE REAGENT FOR DIRECT BILIRUBIN (K910593)Roche Diagnostic Systems, Inc.1991-04-24
ROCHE REAGENT FOR TOTAL BILIRUBIN (K910591)Roche Diagnostic Systems, Inc.1991-04-24
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER (K904783)Industrial Chemical Measurement1991-04-18
CHLORIDE REAGENT (K911297)Intersect Systems, Inc.1991-04-16
REP SPE PLUS (ACID BLUE) SYSTEM (K911468)Helena Laboratories1991-04-16
IMMULITE(TM) TOTAL T4 (K910261)Cirrus Diagnostics, Inc.1991-04-16
OPUS FSH (K911409)Pb Diagnostic Systems, Inc.1991-04-16
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS (K904752)Boehringer Mannheim Corp.1991-04-12
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (K910633)Yellow Springs Instrument Co., Inc.1991-04-12
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 (K910639)Em Diagnostic Systems, Inc.1991-04-12
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 (K910640)Em Diagnostic Systems, Inc.1991-04-12
LH IRMA IMMUNOMAG (K911050)Pantex, Div. Bio-Analysis, Inc.1991-04-12
ENZYMUN-TEST PROGESTERONE (K910683)Boehringer Mannheim Corp.1991-04-08
SYNCHRON LACTATE REAGENT (K910534)Beckman Instruments, Inc.1991-04-08
EQUIPMENT/MATERIAL DECONTAMINATING KIT (K911299)Rohm and Haas Co.1991-04-08
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER (K910185)Beckman Instruments, Inc.1991-04-03
FLOW CYTOMETRY FITC/PE COMPENSATION KIT (K910255)Sigma Diagnostics, Inc.1991-04-03
CIBA CORNING ACS CKMB IMMUNOASSAY (K911121)Ciba Corning Diagnostics Corp.1991-04-03
GLUCOSE V (K910573)Caro Med, Inc.1991-04-03
MICROZYME TSH ENZYME IMMUNOASSAY KIT (K910411)Immunotech Corp.1991-04-03
GEM-PREMIER SYSTEM (K910305)Mallinckrodt Sensor Systems, Inc.1991-04-03
CLEARVIEW HCG (K910946)Unipath , Ltd.1991-04-01
BIO SCAN-BG(TM (K910692)Bio Scan Instrument, Inc.1991-03-29
CHOLESTEROL CALIBRATOR SET (K910962)Casco Standards1991-03-29
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION (K910309)Baxter Healthcare Corp1991-03-29
SLT MICROPLATE WASHER (K910740)Tecan U.S., Ltd.1991-03-27
MINICLINIC OVULATION PREDICTION TEST (K910351)Vanguard Biomedical Corp.1991-03-21
IMMUNOCORP COATED TUBE IRMA HCG (K910349)Immunocorp1991-03-21
CHEMTRAK ACCUMETER CHOLESTEROL TEST (K905405)Chemtrak, Inc.1991-03-19
PANTEX IRMA LH 1251 KIT (K910717)Pantex, Div. Bio-Analysis, Inc.1991-03-19
RENALYZER PRX 90 (K903034)Swedish Trade Council USA1991-03-13
CHEMA CHOL CHOLESTEROL SYSTEM (K904031)Texas Intl. Laboratories, Inc.1991-03-11
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 (K910638)Em Diagnostic Systems, Inc.1991-03-11
BIOTROL LACTATE DEHYDROGENASE (L-P) (K905683)Biotrol, USA, Inc.1991-03-11
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED (K910147)Olympus Corp.1991-03-11
GLUCOSE (HK) REAGENT, UNIVERSAL (K905227)Enzyme Technology, Inc.1991-03-11
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY (K910343)Ciba Corning Diagnostics Corp.1991-03-06
CLINAK(TM) ISE SUBSYSTEM (K910554)Baxter Healthcare Corp1991-03-06
CRP LIPID REAGENT TEST PACK (K905648)Cirrus Diagnostics, Inc.1991-03-06
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS (K905264)Nova Biomedical Corp.1991-03-05
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (K910108)Gds Diagnostics1991-03-04
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED (K910133)Olympus Corp.1991-02-27
PHOSPHORUS (INORGANIC) TEST SYSTEM (K910296)Biochemical Trade, Inc.1991-02-27
COBAS ALPHA (K910222)Roche Diagnostic Systems, Inc.1991-02-27
ELECTROPHORESIS CONTROL (K910160)Seradyn, Inc.1991-02-27
GGT REAGENT (K905618)Amresco, Inc.1991-02-26
ECLIPSE ICA CHOLESTEROL (K905145)Biotope, Inc.1991-02-26
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI (K905820)E.I. Dupont DE Nemours & Co., Inc.1991-02-26
ALBUMIN REAGENT SET (K905776)Biochemical Trade, Inc.1991-02-26
BIOCLONE'S ELEGANCE HCG ELISA KIT (K910420)Bioclone Australia Pty , Ltd.1991-02-26
COULTER DART AST (GOT) REAGENT (K905771)Coulter Electronics, Inc.1991-02-26
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST (K910240)Crystal Diagnostics, Inc.1991-02-26
CK-MB IMMUNOASSAY CONTROL (K905623)Seradyn, Inc.1991-02-22
ECLIPSE ICA ANALYZER (K910302)Biotope, Inc.1991-02-22
ECLIPSE ICA TSH (K910256)Biotope, Inc.1991-02-22
TOTAL PROTEIN REAGENT SET (K905790)Biochemical Trade, Inc.1991-02-21
PHARMACIA DELFIA NEONATAL HTSH KIT (K905710)Pharmacia, Inc.1991-02-21
KINETIC ALKALINE PHOSPHATASE DETERMINATION (K905650)Biochemical Trade, Inc.1991-02-13
STRATUS ESTRADIOL FLUOREMETRIC ENZYME (K910249)Baxter Healthcare Corp1991-02-13
CLEARBLUE EASY (K905742)Unipath , Ltd.1991-02-13
CREATININE (RATE) REAGENT SET (K905619)Biochemical Trade, Inc.1991-02-13
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II (K905477)Em Diagnostic Systems, Inc.1991-02-13
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (K905861)E.I. Dupont DE Nemours & Co., Inc.1991-02-06
ELECTRAPETTE (R) (K910140)Matrix Technologies Corp.1991-02-04
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K910143)Eastman Kodak Company1991-02-04
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (K905814)London Diagnostics, Inc.1991-02-04
BIOTROL BILIRUBIN C & T CONTROL (K905280)Biotrol, USA, Inc.1991-02-04
CIBA CORNING ACS LH IMMUNOASSAY (K910198)Ciba Corning Diagnostics Corp.1991-02-04
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