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Clinical Chemistry

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

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RecordFirmDate
SODIUM/POTASSIUM BUFFER SOLUTION (K791692)Hi Chem, Inc.1979-09-17
GLUCOSE REAGENT (K791685)Hi Chem, Inc.1979-09-17
VENTRE/SEP T4 TEST SET (K791368)Ventrex Laboratories, Inc.1979-09-17
ENZYME STABILIZING REAGENT (ESR) (K791656)Electrophoresis Corp. of America1979-09-17
SODIUM/POTASSIUM CONDITIONING SOLUTION (K791691)Hi Chem, Inc.1979-09-17
CPK ISOENZYME REAGENT (K791655)Electrophoresis Corp. of America1979-09-17
DORN BLOOD CULTURE COLLECTION TUBE (K791303)Wadley Institutes of Molecular Medici1979-09-17
LDH ISOENZYME REAGENT (K791657)Electrophoresis Corp. of America1979-09-17
CALIBRATOR I (K791693)Hi Chem, Inc.1979-09-17
ALKALINE BUFFER (K791688)Hi Chem, Inc.1979-09-17
GELMAN LIPOPROTEIN FRS SET. P/N 51213 (K791606)Gelman Sciences, Inc.1979-09-17
CALIBRATOR II (K791694)Hi Chem, Inc.1979-09-17
WAKO TRIGLYCERIDE (K791597)Wako Pure Chemical Industries, Ltd.1979-09-17
IREX REAL TIME PHASED ARRAY SYSTEM (K791317)Irex Corp.1979-09-17
CO2 REFERENCE REAGENT (K791687)Hi Chem, Inc.1979-09-17
CO2 CUP REAGENT (K791686)Hi Chem, Inc.1979-09-17
PICRIC SOLUTION (K791689)Hi Chem, Inc.1979-09-17
ENZYMATIC REAGENT SET, 4X250 ML. (K791511)Macomb Chemical Co.1979-09-04
DAC-CEL T4 (K791231)Burroughs Wellcome Co.1979-09-04
TSH RIA KIT (K791217)Antibodies, Inc.1979-09-04
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT (K791066)Fermco Biochemics, Inc.1979-09-04
DAC-CEL T3 (K791232)Burroughs Wellcome Co.1979-09-04
MICROMEDIC APS2 (K791324)Micromedic Systems1979-08-28
MODEL MHS-20, ATOMIC ABSORPTION ACCESS (K791074)The Perkin-Elmer Corp.1979-08-22
CATALOG #4-2520 CHLORIDOMETER CHLORIDE (K791312)Buchler Instruments, Inc.1979-08-16
MANUAL MICRO ELISA READER #2-530 (K791302)Dynatech Laboratories, Inc.1979-08-16
ARS, CHEMISTRY (K791313)Mid Tech, Inc.1979-08-16
SPECTRO-SUR SET (K791315)Helena Laboratories1979-08-16
CPK ISOENZYME CONTROL (K791299)Electrophoresis Corp. of America1979-08-16
MEDICOR QUALITY CONTROL BUFFER (K791287)Medicor USA , Ltd.1979-08-16
T3 UPTAKE RADIOIMMUNOASSAY KIT (K791361)Technia Diagnostics , Ltd.1979-08-16
LDH ISOENZYME CONTROL (K791300)Electrophoresis Corp. of America1979-08-16
ANALYZER, SODIUM/POTASSIUM (K791175)Nova Biomedical Corp.1979-08-10
PRE-DENT (K791200)Fichte, Graves, and Hunt1979-08-10
A-GENT QUANTICHROM T4 11A (K790848)Abbott Laboratories1979-08-10
PRISMA (K791297)Lkb Instruments, Inc.1979-08-10
BILIRUBIN CALIBRATOR CONTROL (K791141)Beckman Instruments, Inc.1979-08-10
GLUCOSE (GDH) REAGENT (K791213)Gilford Diagnostics1979-08-10
CENTRIFICHEM SYSTEM 500 (K791180)Union Carbide Corp.1979-08-10
QUANTIMUNE T-3 FIA (K790960)Bio-Rad1979-08-10
CHEMETRICS ANALYZER II (K791296)Chemetrics Corp.1979-08-03
KINETIC DETERMINATION OF UV GLUCOSE (K791110)The Dow Chemical Co.1979-08-03
BUFFERIZER (K791144)Helena Laboratories1979-08-03
HCG RIA PREGNANCY TEST (K791206)Hoffmann-La Roche, Inc.1979-07-30
QUANTIMUNE T-4 FIA (K790576)Bio-Rad1979-07-30
UCG-LYPHOTEST (K791309)Wampole Laboratories1979-07-30
URIDROP SPECIAL (K791197)Ab Medett Produkter1979-07-30
AUTOMATED ELECTROPHORESES MACHINE (K791111)Gelman Sciences, Inc.1979-07-30
IMMUNOSPOT TSH TEST (K791065)Meloy Laboratories, Inc.1979-07-30
FLUOROMATIC ANALYZER AND AUTOSAMPLER (K791329)Bio-Rad1979-07-30
MACOMB NORMAL CONTROL SERUM (K791119)Macomb Chemical Co.1979-07-30
PREG-TEX (K790898)Biologics Intl., Inc.1979-07-30
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR (K791077)Beckman Instruments, Inc.1979-07-24
RIA, INSULIN, DOUBLE ANTIBODY (K790630)Endocrine-Metabolic Center1979-07-24
MODEL 4000, SPECTROPHOTOMETER (K790795)The Perkin-Elmer Corp.1979-07-24
5880 SERIES OF GAS CHROMATOGRAPHS (K791138)Hewlett-Packard Co.1979-07-24
PLUS CHEM S.C.E. REAGENT (K791080)Smithkline Diagnostics, Inc.1979-07-24
PROGESTERONE RADIOIMMUNOASSAY KIT (K791051)Cis Radiopharmaceuticals, Inc.1979-07-24
SPIN CHEM, DETERMINATION OF ALT (GPT) (K791083)Smithkline Diagnostics, Inc.1979-07-17
AMYLASE REAGENT SET (K790797)Alta Diagnostics, Inc.1979-07-17
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL (K791031)Beckman Instruments, Inc.1979-07-17
NORMAL PROTEIN ELECTROPHORESIS CONTROL (K791029)Beckman Instruments, Inc.1979-07-17
LIPASE REAGENT SET (K790796)Alta Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF ALT (GPT) (K791084)Smithkline Diagnostics, Inc.1979-07-17
CARY 210 SERIES, SPECTROPHOTOMETER (K791102)Varian Assoc., Inc.1979-07-17
RABBIT ANTISERUM TO HUMAN CHORIONIC (K790864)Pcl-Ria, Inc.1979-07-17
FERMCOTEST R BUN RATE REAGENT TEST KIT (K791018)Fermco Biochemics, Inc.1979-07-17
HUMAN CHORIONIC GONADOTROPHIN STANDARDS (K790863)Pcl-Ria, Inc.1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF AST (K791082)Smithkline Diagnostics, Inc.1979-07-17
GAMMADAB (125 1) FOLATE RADIOASSAY KIT (K791079)Clinical Assays, Inc.1979-07-17
P.A.P. RIA CONTROL SERUM PACK (K790985)Mallinckrodt Critical Care1979-07-17
SPIN CHEM REAGENT, DETERMINATION OF LDH- (K791081)Smithkline Diagnostics, Inc.1979-07-17
PLUS CHEM, DETERMINATION OF LD (LDH-P) (K791085)Smithkline Diagnostics, Inc.1979-07-17
LABELED HUMAN CHORIONIC GONADOTROPHIN (K790876)Pcl-Ria, Inc.1979-07-17
MULTECON BLOOD GAS CONTROL (K790813)Ortho Diagnostics, Inc.1979-06-28
COULTER ACCU-ZYME IIY-GT REAGENT KIT (K790812)Coulter Electronics, Inc.1979-06-28
UV URIC ACID DETERMINATION (K790834)The Dow Chemical Co.1979-06-28
HPL RIA KIT (K790919)Technia Diagnostics , Ltd.1979-06-28
LANCER HDL SEPARATION KIT (K790865)Sherwood Medical Co.1979-06-28
DIMENSIONALL ROTATOR (K790753)American Hospital Supply Corp.1979-06-28
THYROID CONTROL SERA CODE QAS.101 (K790840)Amersham Corp.1979-06-28
BIOVATION DIGITAL URINOMETER (K790862)Biovation, Inc.1979-06-28
AUTO ENZYMATIC CHOLESTEROL (K790947)Macomb Chemical Co.1979-06-28
ULTRA-FREE (K790445)Millipore Corp.1979-06-28
LIQUID SCINTILLATION COUNTER (K790961)Nuclear Ent. , Ltd.1979-06-28
REAGENT STRIPS FOR URINALYSIS (K790965)Miles Laboratories, Inc.1979-06-28
AUTOPAK CORTISOL TEST DELIVERY SYSTEM (K790906)Micromedic Systems1979-06-27
RIA OF PROGESTERONE (K790911)Calbiochem-Behring Corp.1979-06-27
AUTOPAK TEST DELIVERY SYSTEM (K790907)Micromedic Systems1979-06-27
RIA, TEST SET CENTRIA T3 (K790908)Ventrex Laboratories, Inc.1979-06-27
SPIN CHEM CK-NAC REAGENT (K790917)Smithkline Diagnostics, Inc.1979-06-22
ESKLAB REAGENT TABLETS (K790918)Smithkline Diagnostics, Inc.1979-06-22
CK-NUC REAGENT (K790916)Smithkline Diagnostics, Inc.1979-06-22
BL BILIRUBINOMETER (K790608)Advanced Instruments, Inc.1979-06-15
NUCLEAR SAMPLE READER (K790905)Abbott Laboratories1979-06-15
GLUCOSE (HK) REAGENT (K790786)Gilford Diagnostics1979-06-15
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER (K790653)Nova Corp.1979-06-15
CHOLESTEROL KIT, HDL-DS (K790553)Beckman Instruments, Inc.1979-06-15
PREGNOSTICON PREGNANCY TEST KIT (K790734)Organon, Inc.1979-06-15
ENZYMATIC TRIGLYCERIDES-S.V.R. (K790773)Calbiochem-Behring Corp.1979-06-15
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