meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
64
Latest Decision
1979-12-06

Clearances · page 119 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K792409 ELVI TOTAL IRON BINDING CAPACITY Volu Sol Medical Industries JQF Class I 1979-12-06
K792243 CENTRIA CORTISOL RIA TEST SET Ventrex Laboratories, Inc. CGR Class II 1979-12-06
K792410 ELVI SGOT & SGPT TRANSAMINASE Volu Sol Medical Industries CIS Class II 1979-12-06
K792347 MICRO LOWRY PROTEINTEST Panmed, Inc. JGP Class II 1979-12-06
K792279 AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM Micromedic Systems CFP Class I 1979-12-06
K792376 QUANTITATIVE CONTROL URINE II (HUMAN) Environmental Chemical Specialties JJW Class I 1979-12-06
K792285 TECHNICON C800 SYSTEM Technicon Instruments Corp. JJC Class I 1979-12-06
K792338 DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS Connecticut Diagnostics, Ltd. CIG Class II 1979-12-06
K792346 TWO MINUTE PROTEINTEST Panmed, Inc. CEK Class II 1979-12-06
K792308 CONCEP-7-BHCG Leeco Diagnostics, Inc. JHI Class II 1979-12-06
K792197 HUMAN CHORIONIC GONADOTROPIN (RIA) Nuclear Medical Laboratories, Inc. JHI Class II 1979-12-06
K792337 DONNECT. DIAG. CALCIUM DIAG. REAGENT Connecticut Diagnostics, Ltd. CIC Class II 1979-12-06
K792411 ELVI TOTAL BILIRUBIN & FRACTIONS Volu Sol Medical Industries CIG Class II 1979-12-06
K792254 NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE Nova Biomedical Corp. JFL Class II 1979-12-06
K792396 ELVI CALCIUM Volu Sol Medical Industries CIA Class II 1979-12-06
K792375 ELEVATED LIPID CONTROL Environmental Chemical Specialties JJY Class I 1979-12-06
K792374 QUANTITATIVE CONTROL URINE I (HUMAN) Environmental Chemical Specialties JJW Class I 1979-12-06
K792290 TSH STANDARDS & DILUENT Amersham Corp. JIT Class II 1979-12-06
K792362 BLOOD UREA NITROGEN REAGENT Connecticut Diagnostics, Ltd. JGZ Class II 1979-12-06
K792292 AMES DEXTROMETER REFLECTANCE COLORIMETER Miles Laboratories, Inc. JJQ Class I 1979-12-06
K792339 CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN Connecticut Diagnostics, Ltd. CIX Class II 1979-12-06
K792408 ELVI ALBUMIN Volu Sol Medical Industries CIX Class II 1979-12-06
K792384 PRINCIPAL ANALYTE REFERENCE SERUM Beckman Instruments, Inc. JIX Class II 1979-12-06
K791497 PROSTATIC ACID RADIOIMMUNOASSAY TEST Clinical Assays, Inc. JFH Class II 1979-12-04
K792146 ATOMIC SPECTROSCOPY SYSTEM The Perkin-Elmer Corp. JXR Class I 1979-11-30
K792208 DURAZYME GOT/AST American Monitor Corp. CIT Class II 1979-11-27
K792234 SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES Boehringer Mannheim Corp. CDT Class I 1979-11-27
K791922 HARLECO BRAND CLINICARD LIPASE TEST SET Dade, Baxter Travenol Diagnostics, Inc. CET Class I 1979-11-27
K792188 TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT Abbott Laboratories CDX Class II 1979-11-27
K792063 FOLLICLE STIMULATING HORMONE (FSH) KIT Cis Radiopharmaceuticals, Inc. CGJ Class I 1979-11-20
K792158 3388 REPORTING INTEGRATOR Hewlett-Packard Co. JQP Class I 1979-11-16
K791582 CARDIO CK-B RIA KIT Nuclear Medical Systems, Inc. JHX Class II 1979-11-15
K791735 PAP RIA KIT Nuclear Medical Systems, Inc. JFH Class II 1979-11-15
K792087 MICROFLAME PHOTOMETER Gilford Instrument Laboratories, Inc. JJO Class I 1979-11-13
K792180 CORNING CONFIRM BLOOD GAS QUALITY CONTRO Corning Medical & Scientific JJS Class I 1979-11-13
K791747 HTSH NEONATE RIA DIAGNOSTIC KIT Abbott Laboratories JLW Class II 1979-11-13
K792098 GAS-TRAK BLOOD GAS CONTROL United Diagnostics, Inc. JJS Class I 1979-11-13
K792138 SMAC (SEQUENTIAL MULT. ANALYSIS COMP. Fisher Scientific Co., LLC CEK Class II 1979-11-13
K791216 CENTRIA VITAMIN B12 FOLATE RADIO SET Ventrex Laboratories, Inc. CDD Class II 1979-11-13
K792154 THYROID STIMULATING HORMONE Radioimmunoassay, Inc. JLW Class II 1979-11-13
K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO Dade, Baxter Travenol Diagnostics, Inc. LBS Class I 1979-11-13
K792167 125 I FOLATE SOLID PHASE RADIOASSAY Abbott Laboratories CGN Class II 1979-11-13
K792143 FISHER DIAG. PRIME BLOOD GAS CONTROLS Fisher Scientific Co., LLC JJS Class I 1979-11-13
K792196 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO Photovolt Corp. JJR Class I 1979-11-13
K792189 NORDICLAB TOTAL ESTRIOL RIA TEST Nordiclab Intl. CGI Class I 1979-11-13
K792166 125 I PROLACTIN HORMONE RIA KIT Diagnostic Products Corp. CFT Class I 1979-11-13
K792175 RIANEN, VITAMIN B12 ASSAY SYSTEM New England Nuclear CDD Class II 1979-11-13
K792129 EMIT CLINICAL PROCESSOR-CP 5000 Syva Co. JQP Class I 1979-11-13
K792013 LANCER L-INA HUMAN REFERENCE SERUM Sherwood Medical Industries JIX Class II 1979-11-13
K790808 PROTEIN ASSAY KIT Specialty Medical Industries, Inc. CEK Class II 1979-11-05
K791202 RIA KIT FOR TRYPSIN Cis Radiopharmaceuticals, Inc. JNO Class I 1979-11-05
K791962 WORTHINGTON TRIGLYCERIDES REAGENT SET Worthington Diagnostic Systems JGY Class I 1979-11-05
K792046 URIC ACID STANDARD Gilford Diagnostics JIS Class II 1979-10-30
K792043 PAP-CHECK RIA KIT Serono Laboratories, Inc. JFH Class II 1979-10-30
K791999 (125I) TESTOSTERONE KIT Radioassay Systems Laboratories, Inc. CDZ Class I 1979-10-30
K792025 LYOPHILIZED HDL CHOLESTEROL CONTROLS Helena Laboratories JJY Class I 1979-10-30
K792024 LIPOTROL Helena Laboratories JJY Class I 1979-10-30
K792000 LUTEINIZING HORMONE (LH) RIA Cis Radiopharmaceuticals, Inc. CEP Class I 1979-10-30
K792045 BIOVATION NEPHELOMETER Biovation, Inc. JQX Class I 1979-10-30
K792027 PREGTELL I Central Biological Co. JHJ Class II 1979-10-30
K791893 19091-XXXXX SER. OF GLASS CAPILLARY COL. Hewlett-Packard Co. DII Class I 1979-10-30
K792036 CORTISOL RADIOIMMUNOASSAY SYSTEM Radioimmunoassay, Inc. CGR Class II 1979-10-30
K792041 DHEA-SULFATE TEST SET Wien Laboratories, Inc. JKC Class I 1979-10-30
K791837 VMA BY COLUMN TEST Bio-Rad CDF Class I 1979-10-30
K792023 ESKACHEM, CK-MB REAGENT Smithkline Diagnostics, Inc. JHS Class II 1979-10-30
K791373 ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS Hoffmann-La Roche, Inc. CFE Class II 1979-10-26
K791994 CREATININE DIAG. REAGENT PICRIC ACID Connecticut Diagnostics, Ltd. CGX Class II 1979-10-17
K791968 EIA (ELISA) READER Gilford Instrument Laboratories, Inc. JJQ Class I 1979-10-17
K791990 TECHNICON HDL CHOLESTEROL METHOD Technicon Instruments Corp. LBS Class I 1979-10-17
K791958 SERACON - EL DO27 Bhp Diagnostix, Inc. JJY Class I 1979-10-17
K791706 BE-SURE Precision Products Corp. JHJ Class II 1979-10-17
K791989 TECHNICON C202 SYSTEM Technicon Instruments Corp. CGA Class II 1979-10-17
K791855 CENTRIA TSH RIA Union Carbide Corp. JLW Class II 1979-10-17
K791874 CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD Gilford Diagnostics JIX Class II 1979-10-17
K791707 CENTRIA INSULIN RIA Ventrex Laboratories, Inc. CFP Class I 1979-10-17
K791957 SERACON -LO DO26 Bhp Diagnostix, Inc. JJX Class I 1979-10-11
K791431 TECHNICON FAST-LC SYS. FOR THEOPHYLLINE Technicon Instruments Corp. DPA Class I 1979-10-11
K791375 AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM Micromedic Systems CDP Class II 1979-10-11
K791956 SERACON CAL D025 Bhp Diagnostix, Inc. JIX Class II 1979-10-11
K791609 BE-SURE Biologics Intl., Inc. JHJ Class II 1979-10-02
K791826 CPK CLINI GEL KIT Clinical Sciences, Inc. JHT Class II 1979-10-01
K791723 QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) Organon, Inc. JJT Class I 1979-10-01
K791700 CORTI-SHURE Nuclear Medical Laboratories, Inc. CGR Class II 1979-10-01
K791869 GLUCOSE OXIDASE (FRINDER) KIT Mid Tech, Inc. CGA Class II 1979-10-01
K791825 LY-PRO-TROL #ACS-LP101 Analytical Control Systems, Inc. JJY Class I 1979-10-01
K791836 QUANTIMUNE HFSH RIA Bio-Rad CGJ Class I 1979-10-01
K791827 LDH CLINI GEL KIT Clinical Sciences, Inc. CFE Class II 1979-10-01
K791854 CENTRIA HPL RIA Union Carbide Corp. JMF Class II 1979-10-01
K791663 IMMUCHEM COVALENT COAT SOLID PHASE ASSAY Immuchem Corp. CDP Class II 1979-10-01
K791652 ESTRADIOL KIT BY RIA Radioassay Systems Laboratories, Inc. CHP Class I 1979-09-27
K791754 URIC ACID REAGENT Gilford Diagnostics KNK Class I 1979-09-27
K791728 RSL'S ASSAY PROCEDURE QUANTITATION Radioassay Systems Laboratories, Inc. CGI Class I 1979-09-27
K791588 VENTRE/SEP T3 TEST SET Ventrex Laboratories, Inc. CDP Class II 1979-09-27
K791664 IMMUCHEM COVALENT COAT SOLID PHASE ASSAY Immuchem Corp. CDX Class II 1979-09-27
K791740 SERUM 11-DESOXYCORTISOL I AS TRACER Radioassay Systems Laboratories, Inc. JKB Class I 1979-09-27
K791651 TOTAL ESTROGENS KIT BY RIA Radioassay Systems Laboratories, Inc. JMD Class I 1979-09-27
K791662 IMMUCHEM COVALENT COAT BINDING Immuchem Corp. KHQ Class II 1979-09-27
K791760 GLUCOSE HEXOKINASE COIL REAGENT SYSTEM Fisher Scientific Co., LLC CFR Class II 1979-09-27
K790347 AUTO PAK VITAMIN B-12 Micromedic Systems CDD Class II 1979-09-27
K791128 PTH RIA 200 Institut National Des Radioelements CEW Class II 1979-09-27

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