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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
44
Latest Decision
1976-10-29

Clearances · page 131 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K760479 REAGENT, TOTAL BILIRUBIN DETERMINATION Simmler & Son, Inc. CIG Class II 1976-10-29
K760477 REAGENTS-4 FOR URIC ACID DETERMINATION Simmler & Son, Inc. CDH Class I 1976-10-29
K760410 AMP BUFFER J.T. Baker Chemical Co. CFJ Class II 1976-10-29
K760480 REAGENT, TOTAL PROTEIN DETERMINATION Simmler & Son, Inc. CEK Class II 1976-10-29
K760672 CLINICAL SPECTROPHOTOMETER The Dow Chemical Co. JJQ Class I 1976-10-29
K760411 NAD (SPOONPAK CONTAINER) J.T. Baker Chemical Co. CFJ Class II 1976-10-29
K760407 SULFANILIC ACID J.T. Baker Chemical Co. CIG Class II 1976-10-29
K760473 REAGENT, ALBUMIN DETERMINATION Simmler & Son, Inc. CIX Class II 1976-10-29
K760802 T-3 UPTAKE KIT Diagnostic Products Corp. KHQ Class II 1976-10-29
K760472 INSTRUMENTED SYSTEM FOR URINALYSIS Miles Laboratories, Inc. KQO Class I 1976-10-29
K760475 REAGENT, CALCIUM DETERMINATION Simmler & Son, Inc. CIC Class II 1976-10-29
K760506 HEMAFLOUR ZP Buchler Instruments, Inc. KHO Class I 1976-10-28
K760345 TEST, LACTATE DEHYDROGENASE Princeton Biomedix CFJ Class II 1976-10-27
K760346 ASSAY FOR GAMMA GLUTAMYLTRANSFERASE Princeton Biomedix JPZ Class I 1976-10-27
K760348 REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 Sigma Chemical Co. CCZ Class I 1976-10-27
K760821 REAGENT SYSTEM Sigma Chemical Co. CJT Class I 1976-10-21
K760806 REFEREE AQUEOUS TRIGLYCERIDE STND Analytical Products, Inc. JIS Class II 1976-10-21
K760750 STERILE TUBULAR UNBLEACHED STOCKINETTE Dennison Manufacturing Co. JLG Class I 1976-10-08
K760355 TEST, SEROSONIC ALBUMIN Mallinckrodt Critical Care CIX Class II 1976-10-05
K760349 BILIRUBIN REF., SIGMA STOCK NO. 605-10 Sigma Chemical Co. JIT Class II 1976-10-05
K760621 LANCER PLASTIC TRANSFER PIPETTE Sherwood Medical Industries JRC Class I 1976-10-05
K760347 SET, TRINDER GLUCOSE Princeton Biomedix CGA Class II 1976-10-05
K760261 DETECTOR, MODEL LC-100 FLUORESCENCE The Perkin-Elmer Corp. KHO Class I 1976-09-27
K760026 ULTRAZYME AMYLASE Harleco CIJ Class II 1976-09-21
K760029 ENZYMATIC TRIGLYCERIDE Harleco CDT Class I 1976-09-15
K760028 CPK - ISOENZYMES Harleco JHT Class II 1976-09-15
K760057 TEST, RIA, TRIODOTHYRONINE Smithkline Diagnostics, Inc. CDP Class II 1976-09-13
K760030 CLINICARD PHOSPHORUS Harleco CEO Class I 1976-09-13
K760055 REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER Smithkline Diagnostics, Inc. CFR Class II 1976-08-26
K760247 GLUCOSE REAGENT SYS, SIGMA PROCED. 115 Sigma Chemical Co. CFR Class II 1976-08-26
K760211 ANALYZER, GLUCOSE/UREA/CREATININE Instrumentation Laboratory CO JJC Class I 1976-08-26
K760229 ACID BASE SYSTEM, RADIOMETER AUTOMATED The London Co. CHL Class II 1976-08-26
K760025 ULTRAZYME GT Harleco JPZ Class I 1976-08-26
K760399 REAGENT, P-NITROPHENYL PHOSPHATE J.T. Baker Chemical Co. CJE Class II 1976-08-26
K760024 ULTRAZYME ALKALINE PHOSPHATASE Harleco CJE Class II 1976-08-26
K760023 ULTRAZYME HBD Harleco JMK Class I 1976-08-26
K760232 PRINTER, IL 460 Instrumentation Laboratory CO JJQ Class I 1976-08-26
K760233 TABLE, SAMPLE IL 461 Instrumentation Laboratory CO JJQ Class I 1976-08-26
K760332 SIGMA AMMONIA REAGENT Sigma Chemical Co. JIF Class I 1976-08-23
K760256 TEST SYSTEM, RIA CORTISOL Corning Medical & Scientific CGR Class II 1976-08-11
K760195 REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 Coulter Electronics, Inc. CDT Class I 1976-08-03
K760194 NDC#12739-0010-1 C-ZYME GPT Coulter Electronics, Inc. CKA Class I 1976-08-03
K760262 RADIOASSY KIT, 3H-FOLATE Diamond Shamrock Corp. CGN Class II 1976-08-03
K760193 NDC#12739-0011-1 C-ZYME GOT Coulter Electronics, Inc. CIT Class II 1976-08-03
K760010 COLORIMETRIC DETERMINATION (SGOT/SGPT) The Dow Chemical Co. CIT Class II 1976-07-26
K760227 RADIOIMMUNOASSAY Kallestad Laboratories, Inc. CDX Class II 1976-07-26
K760044 KIT, RIA, HUMAN THYROID HORMONE Bd Becton Dickinson Vacutainer Systems Preanalytic JLW Class II 1976-07-26
K760207 KIT, FOLATE RADIOASSAY SC.7 Amersham Corp. CGN Class II 1976-07-26
K760011 REAGENT, TRIGLYCERIDES The Dow Chemical Co. CDT Class I 1976-07-26
K760135 TEST, RA, QUANTA-COUNT T-4 Bio-Rad CDX Class II 1976-07-20
K760045 KIT, RADIOASSAY, SERUM IRON Bd Becton Dickinson Vacutainer Systems Preanalytic JJA Class I 1976-07-20
K760018 VACUUM TUBES, STERILE (J-VAC) Jelco Laboratories GIM Class II 1976-07-20
K760019 VACUUM TUBES, PEDIATRIC SIZES (J-VAC) Jelco Laboratories GIM Class II 1976-07-20
K760133 PROCEDURE, RED CELL FOLATE ASSAY Bio-Rad CGN Class II 1976-07-20
K760134 PROCEDURE, RA, THYROXINE BINDING PROTEIN Bio-Rad CEE Class II 1976-07-20
K760119 SAMPLER, FLAMELESS (IL MODEL 555) Instrumentation Laboratory CO JXR Class I 1976-07-20
K760131 AGARO-GEL, PRODUCT # A1266 Sigma Chemical Co. JJN Class I 1976-07-20
K760078 REAGENT, RIA TRIIODOTHYRONINE T3 (#200) Oxford Laboratories, Inc. CDP Class II 1976-07-20
K760079 REAGENT, THYROXINE T4 (#210) Oxford Laboratories, Inc. CDX Class II 1976-07-20
K760161 TEST, ACID PHOSPHATASE Princeton Biomedix CJR Class II 1976-07-20
K760132 TEST, RIA, TSH QUANTIMUNE Bio-Rad JLW Class II 1976-07-20
K760009 COLORIMETRIC DETERMINATION (LDH) The Dow Chemical Co. CFH Class II 1976-07-20
K760197 ACCUVETTE II Coulter Electronics, Inc. JRI Class I 1976-07-19
K760086 TRAY, BLOOD SAMPLING (PULSATOR II) Concord Laboratories, Inc. GJE Class II 1976-07-16
K760112 SPECTROPHOTOMETER (JUNIOR III) The Perkin-Elmer Corp. JJQ Class I 1976-07-16

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