meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
67
Latest Decision
1981-07-23

Clearances · page 112 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K811882 KING DIAGNOSTICS GLUCOSE TEST King Diagnostics, Inc. CGA Class II 1981-07-23
K811680 ACCUDEX Biodynamics Corp. JJQ Class I 1981-07-23
K811921 HITACHI 705 CALIBRATOR Boehringer Mannheim Corp. JIX Class II 1981-07-23
K811832 PRECINORM U & PRECIPATH U HUMAN SERUM Boehringer Mannheim Corp. JJX Class I 1981-07-15
K811840 BILIRUBINOMETER Advanced Instruments, Inc. JJQ Class I 1981-07-15
K811817 UROPAPER EIKEN AG Syn-Kit, Inc. JIL Class II 1981-07-15
K811810 URIC ACID TEST Environmental Chemical Specialties KNK Class I 1981-07-15
K811806 QUICK-CHEM COLORIMETER The Dow Chemical Co. JJQ Class I 1981-07-15
K811849 ESKAFLOW TEST FOR GLUCOSE Smithkline Diagnostics, Inc. CFR Class II 1981-07-15
K811749 KING DIAGNOSTICS PHOSPHORUS TEST King Diagnostics, Inc. CEO Class I 1981-07-10
K811421 HCG RADIOIMMUNOASSAY KIT (125I) Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1981-07-10
K811787 QUANTAPHASE T-4 RIA Bio-Rad CDX Class II 1981-07-10
K811310 SODIUM/POTASSIUM REAGENT KITS Chem-Elec, Inc. CEM Class II 1981-07-10
K811747 KING DIAGNOSTICS CHOLESTEROL TEST King Diagnostics, Inc. CGO Class I 1981-07-10
K811857 SELECT-A-FLOW Wenmar Intl. Corp. KNK Class I 1981-07-10
K811709 QUANTIMUNE ESTRIOL RIA Bio-Rad CGI Class I 1981-07-10
K811193 BUN RATE REAGENT Chem-Elec, Inc. CDS Class II 1981-07-10
K810949 MRI PROLACTIN RIA KIT Microanalytic Research, Inc. CFT Class I 1981-07-10
K811746 KING DIAGNOSTICS CHOLESTEROL-FE TEST King Diagnostics, Inc. CHO Class II 1981-07-10
K811748 KING DIAGNOSTICS CALCIUM TEST King Diagnostics, Inc. CIC Class II 1981-07-10
K811760 CHOLESTEROL DETERMINATION Biorent Diagnostic, Inc. CHH Class I 1981-07-10
K811725 TBG DIAGNOSTIC KIT Immuno Assay Corp. CEF Class I 1981-07-10
K811695 HELENA FETAL-TEK 200 MARKER Helena Laboratories JJY Class I 1981-07-01
K811687 URIC ACID TEST King Diagnostics, Inc. KNK Class I 1981-07-01
K811592 LIQUIZYME SINGLE SOLUTION GLUCOSE REAG Amresco, Inc. CGA Class II 1981-07-01
K811694 CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT Baker Instructions Corp. CKA Class I 1981-07-01
K811701 CHLORIDE/CARBON DIOXIDE RATE REAGENT Chem-Elec, Inc. JFS Class II 1981-07-01
K811696 IL #781, SEMI-AUTOMATED LOADER Instrumentation Laboratory CO JQW Class I 1981-07-01
K811659 CREATININE REAGENT Gilford Diagnostics CGX Class II 1981-06-26
K811662 ALBUMIN TEST King Diagnostics, Inc. CIX Class II 1981-06-25
K811573 CARDIOZYME PLUS CK-MB ITEM #65045 Harleco JHW Class II 1981-06-25
K811576 CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) Harleco CGS Class II 1981-06-25
K811661 POTASSIUM TEST King Diagnostics, Inc. CEJ Class II 1981-06-25
K811588 HELENA FETAL-TEK 200 METHOD Helena Laboratories JHG Class II 1981-06-25
K811574 CARDIOZYME PLUS CK-TOTAL ITEM #65046 Harleco CGS Class II 1981-06-25
K811565 ACTH RADIOIMMUNOASSAY KIT Immuno Nuclear Corp. CKG Class II 1981-06-25
K811673 TOTAL PROTEIN TEST King Diagnostics, Inc. CEK Class II 1981-06-25
K811566 C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT Immuno Nuclear Corp. CEW Class II 1981-06-25
K811575 CARDIOZYME PLUS CK-MB ITEM #65045 (G) Harleco JHW Class II 1981-06-25
K811664 CREATININE TEST King Diagnostics, Inc. CGX Class II 1981-06-25
K811418 N-TERMINAL HPTH BY RIA Immuno Nuclear Corp. CEW Class II 1981-06-24
K811553 REAGENT SET TRIGLYCERIDES Boehringer Mannheim Corp. CHI Class I 1981-06-18
K811525 FLEXIGRAM AUTO LOADER SYSTEM Electro-Nucleonics Laboratories, Inc. JJG Class I 1981-06-18
K811558 TSH-P.E.G. Nuclear Diagnostics, Inc. JLW Class II 1981-06-18
K811536 DIRECT TESTOSTERONE RIA Immuchem Corp. CDZ Class I 1981-06-18
K811465 IMIPRAMINE/DISIPRAMINE/LITHIUM Ortho Diagnostic Systems, Inc. JJY Class I 1981-06-12
K811466 AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM Ortho Diagnostic Systems, Inc. JJY Class I 1981-06-12
K811467 DOXEPIN/DESMETHLDOXEPIN/LITHIUM Ortho Diagnostic Systems, Inc. JJY Class I 1981-06-12
K811423 VENTRE/SEP Ventrex Laboratories, Inc. CFP Class I 1981-06-09
K811380 ESTRIOL KIT Cambridge Nuclear Corp. CGI Class I 1981-06-09
K811504 WAKO URIC ACID B TEST Wako Chemicals USA, Inc. KNK Class I 1981-06-09
K811431 TECHNICON STAR SYSTEM Technicon Instruments Corp. JLW Class II 1981-06-09
K810853 CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT The Upjohn Co. CGS Class II 1981-05-29
K811398 EARLY PREGNANCY DETECTION Immuchem Corp. JHI Class II 1981-05-29
K811392 AMES SERA-PAK GLUCOSE REAGENT Miles Laboratories, Inc. CGA Class II 1981-05-29
K811371 NATAL-TEC ESTRIOL Armkel, LLC CGI Class I 1981-05-29
K811370 NATAL-TEC HPL Armkel, LLC JMF Class II 1981-05-29
K811263 TOX TM ANALYZER Abbott Laboratories JQZ Class I 1981-05-29
K811369 NATAL-TEC PROGESTERONE Armkel, LLC JLS Class I 1981-05-29
K811213 T3 (RIA) KIT Immuno Assay Corp. CDP Class II 1981-05-29
K810722 GASTRIN RADIOIMMUNOASSAY TEST Clinical Assays, Inc. CGC Class I 1981-05-27
K811273 CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] Bd Becton Dickinson Vacutainer Systems Preanalytic CHO Class II 1981-05-27
K811257 CORNING 965 CARBON DIOXIDE ANALYZER Corning Medical & Scientific CHS Class II 1981-05-27
K811274 PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JFH Class II 1981-05-27
K811304 LIQUID CHROMATOGRAPHY COLUMNS Supelco, Inc. DPM Class I 1981-05-27
K811289 NOVA 5 Nova Biomedical Corp. JGS Class II 1981-05-27
K811202 ULTRACHEM GLUC-DH, ITEM NO. 65048 Harleco LFR Class II 1981-05-27
K811315 COAT-A-COUNT T4 RIA KIT Diagnostic Products Corp. CDX Class II 1981-05-27
K811194 HITACHI 705 AUTOMATIC BLOOD CHEMISTRY Boehringer Mannheim Corp. JJE Class I 1981-05-27
K811219 KOVA STRIP 6 Icl Scientific JIR Class I 1981-05-21
K811222 INORGANIC PHOSPHORUS REAGENTS Connecticut Diagnostics, Ltd. CED Class I 1981-05-21
K811249 TECHNICON SMAC II SYSTEM & ACCESSORIES Technicon Instruments Corp. JJC Class I 1981-05-21
K811179 OSMOMETER MODEL OM-6010 Fiske Med Science JJM Class I 1981-05-15
K811177 QUANTA PHASE VITAMIN B-12/FOLATE RAD Bio-Rad CGN Class II 1981-05-15
K811150 URINE PREGNANCY TEST STANDARD/CONTR. PK Mallinckrodt Critical Care JJX Class I 1981-05-15
K811182 MULTIANALYTE CONTROLS, ALL KINDS Fisher Scientific Co., LLC JJY Class I 1981-05-15
K811178 HUMAN IGG-ALBUMIN TEST KIT Meloy Laboratories, Inc. CJQ Class II 1981-05-15
K811169 PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT Amersham Corp. JFH Class II 1981-05-15
K811144 ARIA II INSULIN RIA Bd Becton Dickinson Vacutainer Systems Preanalytic CFP Class I 1981-05-15
K811143 PH/BLOOD GAS CONTROL (ABC) Instrumentation Laboratory CO JJS Class I 1981-05-13
K810584 PHADEBAS ISOAMYLASE TEST Pharmacia, Inc. CIW Class II 1981-05-13
K811116 HCG RADIOIMMUNOASSAY Hoffmann-La Roche, Inc. JHI Class II 1981-05-13
K811111 AUTOMATIC ELISA READER Artek Systems Corp. JJQ Class I 1981-05-08
K811024 LUTEINIZING HORMONE DIRECT RIA KIT 125/I Immunalysis Corporation CEP Class I 1981-05-08
K811138 NUTRIENT AGAR Acumedia Manufacturers, Inc. JSQ Class I 1981-05-05
K811001 MICROERMA SYSTEM Dynatech Corp. JQW Class I 1981-05-01
K811100 GELMAN ELECTROPHORESIS CONTROL Gelman Sciences, Inc. JJY Class I 1981-05-01
K811074 GLUCOSE REAGENT-ENZYMATIC-COLOR 500 Reagents Applications, Inc. CGA Class II 1981-04-29
K811070 125 I-T4 RIA TEST KIT Intl. Immunoassay Laboratories, Inc. CDX Class II 1981-04-29
K810993 GLUCOSCAN TEST STRIPS Lifescan, Inc. CGA Class II 1981-04-29
K811036 FILTER SAMPLER BLOOD SERUM FILTER Glasrock Plastics, Inc. JKA Class II 1981-04-29
K810992 HELENA VMA-SMC COLUMN METHOD Helena Laboratories CDF Class I 1981-04-29
K811019 LKB 4460 FLUORIMETER Lkb Instruments, Inc. KHO Class I 1981-04-29
K810967 IN-VITRO TBG RADIOIMMUNOASSAY TEST Clinical Assays, Inc. CEE Class II 1981-04-23
K810968 BCD-HPP41C INTERFACE Dynatech Corp. JQP Class I 1981-04-23
K810997 WORTHINGTON CK (NAC) REAGENT SET Worthington Diagnostic Systems JHS Class II 1981-04-23
K810938 MASS SPECTROMETER-MEDSPECT II Allied Healthcare Products, Inc. DOP Class I 1981-04-23
K802447 GOT ISOENZYME ASSAY EIKEN KIT Syn-Kit, Inc. CIT Class II 1981-04-17
K810963 BIO SET TM SUBSTRATE CALIBRATORS Boehringer Mannheim Corp. JIS Class II 1981-04-17
K810948 RADIOIMMUNOASSAY THYROID STIM. HORM. KIT Endocrine-Metabolic Center JLW Class II 1981-04-17

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