meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1979-09-27

Clearances · page 120 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K791835 CORALENT COAT 125I CORTISOL RADIOIMM. Radioassay Systems Laboratories, Inc. CGR Class II 1979-09-27
K791640 COULTER ACCU-ZYME II ENZYMATIC REAGENT Coulter Electronics, Inc. CDT Class I 1979-09-24
K791695 CONTRO I Hi Chem, Inc. JJY Class I 1979-09-24
K791669 GLUCOSE OXIDASE REAGENT SET Macomb Chemical Co. CGA Class II 1979-09-24
K791641 SGPT REAGENT SET MODIFICATION American Monitor Corp. CKA Class I 1979-09-24
K791301 ORTHO TSH RIA KIT Ortho Diagnostics, Inc. JLW Class II 1979-09-24
K791696 CONTRO II Hi Chem, Inc. JJY Class I 1979-09-24
K791679 NADH OXIDATION, AST/SGOT American Monitor Corp. CIT Class II 1979-09-24
K791708 INORGANIC PHOSPHORUS REAGENT Gilford Diagnostics CEO Class I 1979-09-24
K791661 SYSTEM CONTROLLER 720 SERIES Waters Assoc., Inc. KIE Class I 1979-09-24
K791712 ANGIOTENSIN CONVERTING ENZYME ASSAY SYS Ventrex Laboratories, Inc. KQN Class II 1979-09-19
K791368 VENTRE/SEP T4 TEST SET Ventrex Laboratories, Inc. CDX Class II 1979-09-17
K791655 CPK ISOENZYME REAGENT Electrophoresis Corp. of America JHY Class II 1979-09-17
K791690 CHOLORDE REAGENT Hi Chem, Inc. JFS Class II 1979-09-17
K791686 CO2 CUP REAGENT Hi Chem, Inc. JFL Class II 1979-09-17
K791689 PICRIC SOLUTION Hi Chem, Inc. CGX Class II 1979-09-17
K791597 WAKO TRIGLYCERIDE Wako Pure Chemical Industries, Ltd. CDT Class I 1979-09-17
K791405 125I LEUTINIZING HORMONE RIA KIT Diagnostic Products Corp. CEP Class I 1979-09-17
K791606 GELMAN LIPOPROTEIN FRS SET. P/N 51213 Gelman Sciences, Inc. JHO Class I 1979-09-17
K791688 ALKALINE BUFFER Hi Chem, Inc. CGX Class II 1979-09-17
K791693 CALIBRATOR I Hi Chem, Inc. JIX Class II 1979-09-17
K791303 DORN BLOOD CULTURE COLLECTION TUBE Wadley Institutes of Molecular Medici JKA Class II 1979-09-17
K791656 ENZYME STABILIZING REAGENT (ESR) Electrophoresis Corp. of America CFE Class II 1979-09-17
K791692 SODIUM/POTASSIUM BUFFER SOLUTION Hi Chem, Inc. CEM Class II 1979-09-17
K791687 CO2 REFERENCE REAGENT Hi Chem, Inc. JFL Class II 1979-09-17
K791657 LDH ISOENZYME REAGENT Electrophoresis Corp. of America CFE Class II 1979-09-17
K791654 NORMAL CONTROL Electrophoresis Corp. of America JJY Class I 1979-09-17
K791694 CALIBRATOR II Hi Chem, Inc. JIX Class II 1979-09-17
K791317 IREX REAL TIME PHASED ARRAY SYSTEM Irex Corp. CDP Class II 1979-09-17
K791691 SODIUM/POTASSIUM CONDITIONING SOLUTION Hi Chem, Inc. JGS Class II 1979-09-17
K791685 GLUCOSE REAGENT Hi Chem, Inc. CGA Class II 1979-09-17
K791511 ENZYMATIC REAGENT SET, 4X250 ML. Macomb Chemical Co. CHH Class I 1979-09-04
K791217 TSH RIA KIT Antibodies, Inc. JLW Class II 1979-09-04
K791231 DAC-CEL T4 Burroughs Wellcome Co. CDX Class II 1979-09-04
K791066 GLUCOSE GOD-PAP TRINDER METHOD TEST KIT Fermco Biochemics, Inc. CGA Class II 1979-09-04
K791232 DAC-CEL T3 Burroughs Wellcome Co. CDP Class II 1979-09-04
K791324 MICROMEDIC APS2 Micromedic Systems JQW Class I 1979-08-28
K791074 MODEL MHS-20, ATOMIC ABSORPTION ACCESS The Perkin-Elmer Corp. JXR Class I 1979-08-22
K791299 CPK ISOENZYME CONTROL Electrophoresis Corp. of America JJT Class I 1979-08-16
K791361 T3 UPTAKE RADIOIMMUNOASSAY KIT Technia Diagnostics , Ltd. KHQ Class II 1979-08-16
K791302 MANUAL MICRO ELISA READER #2-530 Dynatech Laboratories, Inc. JJQ Class I 1979-08-16
K791287 MEDICOR QUALITY CONTROL BUFFER Medicor USA , Ltd. JJS Class I 1979-08-16
K791313 ARS, CHEMISTRY Mid Tech, Inc. JJY Class I 1979-08-16
K791312 CATALOG #4-2520 CHLORIDOMETER CHLORIDE Buchler Instruments, Inc. JIT Class II 1979-08-16
K791315 SPECTRO-SUR SET Helena Laboratories JIS Class II 1979-08-16
K791300 LDH ISOENZYME CONTROL Electrophoresis Corp. of America JJT Class I 1979-08-16
K791141 BILIRUBIN CALIBRATOR CONTROL Beckman Instruments, Inc. JJX Class I 1979-08-10
K791175 ANALYZER, SODIUM/POTASSIUM Nova Biomedical Corp. CEM Class II 1979-08-10
K790960 QUANTIMUNE T-3 FIA Bio-Rad CDP Class II 1979-08-10
K791213 GLUCOSE (GDH) REAGENT Gilford Diagnostics LFR Class II 1979-08-10
K791200 PRE-DENT Fichte, Graves, and Hunt GIM Class II 1979-08-10
K791297 PRISMA Lkb Instruments, Inc. JJE Class I 1979-08-10
K790848 A-GENT QUANTICHROM T4 11A Abbott Laboratories KLI Class II 1979-08-10
K791180 CENTRIFICHEM SYSTEM 500 Union Carbide Corp. JJG Class I 1979-08-10
K791144 BUFFERIZER Helena Laboratories JJN Class I 1979-08-03
K791110 KINETIC DETERMINATION OF UV GLUCOSE The Dow Chemical Co. LFR Class II 1979-08-03
K791296 CHEMETRICS ANALYZER II Chemetrics Corp. JJE Class I 1979-08-03
K791206 HCG RIA PREGNANCY TEST Hoffmann-La Roche, Inc. JHI Class II 1979-07-30
K790898 PREG-TEX Biologics Intl., Inc. JHJ Class II 1979-07-30
K791329 FLUOROMATIC ANALYZER AND AUTOSAMPLER Bio-Rad KHO Class I 1979-07-30
K791065 IMMUNOSPOT TSH TEST Meloy Laboratories, Inc. JLW Class II 1979-07-30
K791309 UCG-LYPHOTEST Wampole Laboratories JHJ Class II 1979-07-30
K791197 URIDROP SPECIAL Ab Medett Produkter KNK Class I 1979-07-30
K791119 MACOMB NORMAL CONTROL SERUM Macomb Chemical Co. JJY Class I 1979-07-30
K790576 QUANTIMUNE T-4 FIA Bio-Rad CDX Class II 1979-07-30
K791111 AUTOMATED ELECTROPHORESES MACHINE Gelman Sciences, Inc. JJN Class I 1979-07-30
K790795 MODEL 4000, SPECTROPHOTOMETER The Perkin-Elmer Corp. JXR Class I 1979-07-24
K791080 PLUS CHEM S.C.E. REAGENT Smithkline Diagnostics, Inc. CIT Class II 1979-07-24
K791138 5880 SERIES OF GAS CHROMATOGRAPHS Hewlett-Packard Co. KZQ Class I 1979-07-24
K791051 PROGESTERONE RADIOIMMUNOASSAY KIT Cis Radiopharmaceuticals, Inc. JLS Class I 1979-07-24
K791077 BECKMAN ELECTROPHORESIS OVEN/INCUBATOR Beckman Instruments, Inc. JRJ Class I 1979-07-24
K790630 RIA, INSULIN, DOUBLE ANTIBODY Endocrine-Metabolic Center CFP Class I 1979-07-24
K791081 SPIN CHEM REAGENT, DETERMINATION OF LDH- Smithkline Diagnostics, Inc. CFJ Class II 1979-07-17
K790797 AMYLASE REAGENT SET Alta Diagnostics, Inc. KHM Class II 1979-07-17
K791031 ABNORMAL PROTEIN ELECTROPHORESIS CONTROL Beckman Instruments, Inc. JJX Class I 1979-07-17
K791079 GAMMADAB (125 1) FOLATE RADIOASSAY KIT Clinical Assays, Inc. CGN Class II 1979-07-17
K791102 CARY 210 SERIES, SPECTROPHOTOMETER Varian Assoc., Inc. JJQ Class I 1979-07-17
K790796 LIPASE REAGENT SET Alta Diagnostics, Inc. CET Class I 1979-07-17
K790864 RABBIT ANTISERUM TO HUMAN CHORIONIC Pcl-Ria, Inc. JHI Class II 1979-07-17
K791085 PLUS CHEM, DETERMINATION OF LD (LDH-P) Smithkline Diagnostics, Inc. CFJ Class II 1979-07-17
K791029 NORMAL PROTEIN ELECTROPHORESIS CONTROL Beckman Instruments, Inc. JJX Class I 1979-07-17
K791084 PLUS CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. CKA Class I 1979-07-17
K791083 SPIN CHEM, DETERMINATION OF ALT (GPT) Smithkline Diagnostics, Inc. CKA Class I 1979-07-17
K791082 SPIN CHEM REAGENT, DETERMINATION OF AST Smithkline Diagnostics, Inc. CIT Class II 1979-07-17
K791018 FERMCOTEST R BUN RATE REAGENT TEST KIT Fermco Biochemics, Inc. CDS Class II 1979-07-17
K790863 HUMAN CHORIONIC GONADOTROPHIN STANDARDS Pcl-Ria, Inc. JHI Class II 1979-07-17
K790876 LABELED HUMAN CHORIONIC GONADOTROPHIN Pcl-Ria, Inc. JHI Class II 1979-07-17
K790985 P.A.P. RIA CONTROL SERUM PACK Mallinckrodt Critical Care JJT Class I 1979-07-17
K790840 THYROID CONTROL SERA CODE QAS.101 Amersham Corp. JJY Class I 1979-06-28
K790834 UV URIC ACID DETERMINATION The Dow Chemical Co. CDO Class I 1979-06-28
K790813 MULTECON BLOOD GAS CONTROL Ortho Diagnostics, Inc. JJS Class I 1979-06-28
K790862 BIOVATION DIGITAL URINOMETER Biovation, Inc. JRE Class I 1979-06-28
K790965 REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. CDM Class I 1979-06-28
K790919 HPL RIA KIT Technia Diagnostics , Ltd. JMF Class II 1979-06-28
K790445 ULTRA-FREE Millipore Corp. JRL Class I 1979-06-28
K790961 LIQUID SCINTILLATION COUNTER Nuclear Ent. , Ltd. JJJ Class I 1979-06-28
K790865 LANCER HDL SEPARATION KIT Sherwood Medical Co. LBR Class I 1979-06-28
K790947 AUTO ENZYMATIC CHOLESTEROL Macomb Chemical Co. CHH Class I 1979-06-28
K790812 COULTER ACCU-ZYME IIY-GT REAGENT KIT Coulter Electronics, Inc. JPZ Class I 1979-06-28
K790753 DIMENSIONALL ROTATOR American Hospital Supply Corp. JRQ Class I 1979-06-28

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.