meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
62
Latest Decision
1981-04-17

Clearances · page 113 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K810952 CORNING VITAMIN B12 FOLATE DEFIC. CONTR. Corning Medical & Scientific JJY Class I 1981-04-17
K810665 GILUCOCHEK REFLECTANCE METER Lifescan, Inc. JJQ Class I 1981-04-17
K810936 CHORIO-SHURE Nuclear Medical Laboratories, Inc. JHI Class II 1981-04-17
K810965 DATA-ZYME TRIGLYCERIDE Data Medical Associates, Inc. CDT Class I 1981-04-17
K810964 BIO SET TM PHOSPHOROUS CALIBRATOR Boehringer Mannheim Corp. JIX Class II 1981-04-17
K810215 DAC-CEL HCG Burroughs Wellcome Co. JHI Class II 1981-04-17
K810867 FOLLICLE STIMULATING HORMONE (FSH) Pcl-Ria, Inc. JIS Class II 1981-04-14
K810891 COAT-A-COUNT CORTISOL RIA KIT Diagnostic Products Corp. CGR Class II 1981-04-14
K810905 ISOMUNE-CK Hoffmann-La Roche, Inc. JHW Class II 1981-04-14
K810870 GEMENI CK-MB ISOENZYME ABNORMAL SERUM Gemini, Inc. JJT Class I 1981-04-14
K810906 TRI-LEVEL NDI CONTROL Nuclear Diagnostics, Inc. JJY Class I 1981-04-14
K810861 CREATINE KINASE MB ISOENZYME IMMUNO UV The Dow Chemical Co. JHW Class II 1981-04-14
K810917 KOVA TROL I HUMAN URINE (DRIED) Icl Scientific JJW Class I 1981-04-14
K810852 FOLLICLE STIMULATING HORMONE ANTISERUM Pcl-Ria, Inc. CGJ Class I 1981-04-08
K810833 SORVALL RT6000 REFRIGERATED TABLETOP E.I. Dupont DE Nemours & Co., Inc. JQC Class I 1981-04-08
K810550 SILVER ANODE Nobel Scientific Industries, Inc. JFS Class II 1981-04-08
K810549 THERMAL PRINTER PAPER Nobel Scientific Industries, Inc. JJE Class I 1981-04-08
K810857 T3 UPTAKE KIT Immuno Assay Corp. KHQ Class II 1981-04-08
K810829 ACRODISC Gelman Sciences, Inc. JRL Class I 1981-04-08
K810811 T4 RIA KIT Immuno Assay Corp. CDX Class II 1981-04-07
K810798 TECHNICON STAR SYSTEM T3 RIA METHOD Technicon Instruments Corp. CDP Class II 1981-04-07
K810816 PREFILLED ARTERIAL BLOOD SAMPLING SYRING Current Technologies, Inc. JKA Class II 1981-04-07
K810762 API TURBICITY STANDARD Analytical Products, Inc. JKP Class I 1981-04-03
K810794 A-GENT UREA NITROGEN Abbott Laboratories CDQ Class II 1981-04-01
K810804 PROGESTERONE KIT Cambridge Nuclear Corp. JLS Class I 1981-04-01
K810724 CORNING 178 BLOOD GAS ANALYZER Corning Medical & Scientific CHL Class II 1981-03-31
K810669 PANTRAK E.K. Calbiochem-Behring Corp. CIW Class II 1981-03-31
K810718 C-PEPTICE REAGENTS Calbiochem-Behring Corp. JKD Class I 1981-03-31
K810667 AMERLEX ESTRIOL RIA KIT Amersham Corp. CGI Class I 1981-03-31
K810639 SERALYZER SYSTEM Miles Laboratories, Inc. CGA Class II 1981-03-31
K810662 LEECO LH-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. CEP Class I 1981-03-31
K810673 ENZYMATIC CHOLESTEROL Pointe Scientific, Inc., CHH Class I 1981-03-31
K810618 AMPULED FLAME PHOTOMETER STANDARDS United Diagnostics, Inc. JIS Class II 1981-03-31
K810742 AQUEOUS TRIOLEIN STANDARDS & KITS Supelco, Inc. JIS Class II 1981-03-31
K810736 LUMINESCENCE PHOTOMETER 100 SERIES Sai Technology JJQ Class I 1981-03-31
K810717 COAT-A-COUNT T3 UPTAKE KIT Diagnostic Products Corp. KHQ Class II 1981-03-31
K810664 ISOLATOR SYSTEM E.I. Dupont DE Nemours & Co., Inc. JKA Class II 1981-03-31
K810695 ESTRIOL RADIOIMMUNOASSAY TEST KIT Serono Laboratories, Inc. CHP Class I 1981-03-31
K810743 LECITHIN-SPINGOMYELIN STAND. & KITS Supelco, Inc. JIS Class II 1981-03-31
K810727 AST-UV (PLP-ACTIVATED) DETERMINATION The Dow Chemical Co. CIT Class II 1981-03-31
K810741 LUTEINIZING HORMONE Pcl-Ria, Inc. CEP Class I 1981-03-31
K810674 GLUCOSE OXIDASE Pointe Scientific, Inc., CGA Class II 1981-03-31
K810680 ENZYMATIC TRIGLYCERIDE Pointe Scientific, Inc., CDT Class I 1981-03-31
K810725 QUALITROL #65057 Harleco JJT Class I 1981-03-31
K810754 LUTENIZING HORMONES Pcl-Ria, Inc. CEP Class I 1981-03-31
K810619 710 FLUOROMETER/DENSITOMETER Corning Medical & Scientific JQT Class I 1981-03-27
K810663 LEECO FSH-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. CGJ Class I 1981-03-27
K810204 17B ESTRADIOL Pantex, Div. Bio-Analysis, Inc. CHP Class I 1981-03-27
K810631 DPM CALCULATOR Iso-Data, Inc. JQP Class I 1981-03-27
K810587 EMIT-TFG PRISMA THYROXINE CALIBRATORS Syva Co. JIS Class II 1981-03-24
K810581 FACT* HOME PREGNANCY TEST Ortho Pharmaceutical Corp. JHJ Class II 1981-03-17
K810586 EMIT-TFG PRISMA THYROXINE ASSAY Syva Co. KLI Class II 1981-03-17
K810596 CENTRIFI CHEM SYSTEM 400 ANALYZER Union Carbide Corp. JJE Class I 1981-03-17
K810615 CORNING 925 CHLORIDE METER Corning Medical & Scientific JFS Class II 1981-03-17
K810536 ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB The Perkin-Elmer Corp. JXR Class I 1981-03-17
K810567 GERMCO TEST R GLUCOSE TEST KIT Fermco Biochemics, Inc. CGA Class II 1981-03-13
K810534 GEMENI QUICK-MB SEPARATION KIT Gemini, Inc. JHT Class II 1981-03-11
K810394 PRE-VAP CAPS Sherman Boosalis JJC Class I 1981-03-06
K810509 DIGITAL DISPENSING PUMP Dynatech Corp. JQW Class I 1981-03-06
K810214 DAC-CEL DIAGNATAL Burroughs Wellcome Co. JHI Class II 1981-03-06
K810511 BECKMAN DU-8 SPECTROPHOTOMETER Beckman Instruments, Inc. JJQ Class I 1981-03-06
K810514 SANDARE NITROPRUSSIDE TEST PROCEDURE Sandare Chemical Co., Inc. JLC Class I 1981-03-04
K810381 HTSH RIABEAD DIAGNOSTIC KIT Abbott Laboratories CGJ Class I 1981-02-26
K810405 CHOLESTEROL REAGENT Gilford Diagnostics CHH Class I 1981-02-26
K810087 UREA NITROGEN, KINETIC Bio-Analytics Laboratories, Inc. JGZ Class II 1981-02-26
K803234 ESKACHEM PAP REAGENT Smithkline Diagnostics, Inc. JFH Class II 1981-02-26
K810434 GAMMA-GT REAGENT SYSTEM American Monitor Corp. JQB Class I 1981-02-26
K810345 LIQUID SCINTILLATION SPECTROPHOTOMETER Beckman Instruments, Inc. JJJ Class I 1981-02-25
K810302 QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM Bio-Rad CEP Class I 1981-02-25
K810304 MODEL LC-85 UV DETECTOR The Perkin-Elmer Corp. LDM Class I 1981-02-25
K810355 ALT (UV) TEST Boehringer Mannheim Corp. CKA Class I 1981-02-23
K810351 RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE Endocrine-Metabolic Center CDP Class II 1981-02-23
K810356 BICARBONATE TEST Boehringer Mannheim Corp. KHS Class II 1981-02-23
K810390 AST (UV) TEST Boehringer Mannheim Corp. CIT Class II 1981-02-23
K810308 ARTERIAL MICROCOLLECTION SET American Dade CHL Class II 1981-02-19
K810213 DAC-CEL TSH Burroughs Wellcome Co. JLW Class II 1981-02-10
K810135 MODEL AM 721 ELECTROLYTE ANALYZER Abbott Diagnostics JGS Class II 1981-02-10
K810212 DAC-CEL T3 UPTAKE Burroughs Wellcome Co. KHQ Class II 1981-02-10
K810231 CODE IM 2050 AMERLEX FREE T4 RIA KIT Amersham Corp. CEC Class II 1981-02-10
K810232 LEECO P.A.P. - QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. JFH Class II 1981-02-10
K810211 T3 RIA KIT E. R. Squibb & Sons, Inc. CDP Class II 1981-02-10
K810203 MODEL AM 722 Applied Medical Technologies JFP Class II 1981-02-10
K810253 SODIUM & POTASSIUM TEST KIT Mallinckrodt Critical Care JGM Class II 1981-02-10
K810261 EUROCHIMA UREA NITROGEN Volu Sol Medical Industries CDL Class II 1981-02-10
K810192 ENDAB CORTISOL KIT Immunotech Corp. CGR Class II 1981-02-06
K803312 MICROMEDIC AUTOMATIC COMPUTING CENTER Micomedic Systems JQP Class I 1981-02-04
K810186 MICROMEDIC SYSTEMS' AUTOPAK Micromedic Systems CGN Class II 1981-02-04
K810136 URIC ACID REAGENT SYSTEM American Monitor Corp. KNK Class I 1981-02-02
K810105 BCA 1000 Biodynamics Corp. JJQ Class I 1981-02-02
K810092 CHOLESTEROL STANDARD Anco Medical Reagents & Assoc. JIS Class II 1981-02-02
K810055 STANBIO BILIRUBIN TEST SET Stanbio Laboratory CIG Class II 1981-02-02
K810144 ALK-PHOS BIOPAK GEL Bioware Products CIN Class II 1981-02-02
K810129 CENTRIFICHEM SYSTEM 500 Union Carbide Corp. JJE Class I 1981-02-02
K810083 LDH-L LIQUID ENZYMATIC, KINETIC KIT Bio-Analytics Laboratories, Inc. CFJ Class II 1981-01-28
K810088 URIC ACID (TPTZ) COLORINMETRIC Bio-Analytics Laboratories, Inc. CDH Class I 1981-01-28
K810086 IRON & TICB Bio-Analytics Laboratories, Inc. JQF Class I 1981-01-28
K802856 MINIATURE ION SELECTIVE ELECTRODES Ionetics, Inc. JFP Class II 1981-01-28
K810085 IRON KIT Bio-Analytics Laboratories, Inc. CFM Class I 1981-01-28
K802886 NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- Nuclear Diagnostics, Inc. JFH Class II 1981-01-28
K810089 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI Anco Medical Reagents & Assoc. CGE Class II 1981-01-26

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