meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
63
Latest Decision
1980-02-13

Clearances · page 118 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K800128 CENTRIFICHEM BUN Union Carbide Corp. CDQ Class II 1980-02-13
K800165 VENTRE/SEP T3 UPTAKE RADIOASSAY Ventrex Laboratories, Inc. KHQ Class II 1980-02-13
K800141 ACCUSTROKE PIPET Beckman Instruments, Inc. JQW Class I 1980-02-13
K800127 CENTRIFICHEM CK Union Carbide Corp. CGS Class II 1980-02-13
K800116 DURAZYME GOT/AST American Monitor Corp. CIT Class II 1980-02-13
K800106 LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS Radioimmunoassay, Inc. CEP Class I 1980-02-13
K800169 AMES RIALYZE - CHROMATOGRAPHY TUBES Miles Laboratories, Inc. CDX Class II 1980-02-13
K800120 LDH (L-P) REAGENT Gilford Diagnostics CFJ Class II 1980-02-13
K800115 DURAZYME GPT/ALT American Monitor Corp. CKA Class I 1980-02-13
K800075 MICROMEDIC PUNCH & ELUTER Micromedic Systems JQW Class I 1980-02-13
K800131 CENTRIFICHEM ALP/ALKALINE PHOSPHATASE Union Carbide Corp. CJE Class II 1980-02-11
K800057 MICRO ELISA MINI READER Dynatech Laboratories, Inc. JJQ Class I 1980-02-11
K800062 PIPET CALIBRATION KIT Streck Laboratories, Inc. JIS Class II 1980-02-11
K800071 BUN REAGENT KIT Fisher Scientific Co., LLC CDS Class II 1980-02-05
K800054 KODAK EKTACHEM ELECTROLYTE ANALYZER Eastman Kodak Company CEM Class II 1980-02-05
K800065 ASI REAGENT Gilford Diagnostics CIT Class II 1980-02-05
K800070 GLUCOSE OXIDASE REAGENT KIT Fisher Scientific Co., LLC CGA Class II 1980-02-05
K792696 MICROPITETTE Meridian Diagnostics, Inc. JRC Class I 1980-02-01
K800003 CORTEX DOUBLE HELIX SAMPLER Cortex Research Corp. GLE Class I 1980-02-01
K792548 ALKALINE PHOSPHATASE MARKER Electrophoresis Corp. of America CIN Class II 1980-01-29
K792545 URIC ACID KIT Alta Diagnostics, Inc. KNK Class I 1980-01-29
K792553 AGAROSE BARBITAL-EDTA BUFFER Electrophoresis Corp. of America JJN Class I 1980-01-29
K792551 ALKALINE PHOSPHATASE REAGENT Electrophoresis Corp. of America CJH Class II 1980-01-29
K800048 LDC CONSTAMETRIC III HIGHT PRESS. SOL. Laboratory Data Control KIE Class I 1980-01-29
K792547 AGAROSE BARBITAL BUFFER Electrophoresis Corp. of America JJN Class I 1980-01-29
K800055 H-I-M-TEST FOR DETECTING HUMAN CHOR. GON Technam, Inc. JHJ Class II 1980-01-29
K800045 QUANTIMUNE CORTISOL RIA CORTISOL RADIO- Bio-Rad CGR Class II 1980-01-23
K800053 KODAK EKTACHEM FOUR CHEMISTRY ANALYZER Eastman Kodak Company JJE Class I 1980-01-23
K800049 DELTA TEST AMYLASE UV Bd Becton Dickinson Vacutainer Systems Preanalytic JFJ Class II 1980-01-23
K800043 CESIUM DILUENT (1.5 MM/L) Gilford Diagnostics JIX Class II 1980-01-21
K800035 PENTEX LIPOPROTEIN CHOLESTEROL SOLU. Miles Laboratories, Inc. JJX Class I 1980-01-21
K792233 CENTRIA FSH RIA Union Carbide Corp. CGJ Class I 1980-01-21
K800041 SODIUM/POTASSIUM 140/5 MEQ/L) Gilford Diagnostics JIX Class II 1980-01-21
K800047 LDC UVIII FIXED WAVELENGTH ULTRAVIOLET Laboratory Data Control KIE Class I 1980-01-21
K800016 DUPONT ACA ION SELECTIVE ELECTRODE E.I. Dupont DE Nemours & Co., Inc. CEM Class II 1980-01-21
K800038 ALT REAGENT Gilford Diagnostics CKA Class I 1980-01-21
K800040 SODIUM/POTASSIUM (100/100 MEQ/E) Gilford Diagnostics JIX Class II 1980-01-21
K800028 WORTHINGTON FLOZYME* CPK (340NM) Worthington Diagnostic Systems JHS Class II 1980-01-21
K800036 TOTAL ESTRIOL RIA KIT Amersham Corp. CGI Class I 1980-01-21
K800042 LITHIUM STANDARD (1MM/L) Gilford Diagnostics JIS Class II 1980-01-21
K792723 BLOOD FLUID FILTERS Dade, Baxter Travenol Diagnostics, Inc. JKA Class II 1980-01-21
K792658 COBAS-BLO REAGENTS (LACTATE DEHYDRO Hoffmann-La Roche, Inc. CFJ Class II 1980-01-17
K792587 VENOJECT AUTOSEP Kimble-Terumo, Inc. JKA Class II 1980-01-17
K792671 COBAS-BIO CENTRIFUGAL ANALYZER Hoffmann-La Roche, Inc. JJG Class I 1980-01-17
K792439 ANALYTE CORTISOL Technicon Instruments Corp. CGR Class II 1980-01-17
K792662 AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM Micromedic Systems KHQ Class II 1980-01-17
K792605 CHLORIDE REAGENT Gilford Diagnostics CHJ Class II 1980-01-16
K792607 T3 UPTAKE (T3U) REAGENTS Dade, Baxter Travenol Diagnostics, Inc. KHQ Class II 1980-01-16
K792555 ELVI NON-ESTERIFIED FATTY ACIDS Volu Sol Medical Industries JLH Class I 1980-01-16
K792599 TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY Nuclear Diagnostics, Inc. CDX Class II 1980-01-16
K792534 NEOCHROME II GLUCOSE, #4044 American Monitor Corp. CGA Class II 1980-01-16
K792504 RIA-QUANT CK-MB TEST KIT Mallinckrodt Critical Care JHX Class II 1980-01-16
K792652 LEECO P.A.P. QUANT. DIAGNOSTIC KIT Leeco Diagnostics, Inc. JFH Class II 1980-01-16
K792562 IMMUNOSTAT TSH TEST Meloy Laboratories, Inc. JLW Class II 1980-01-16
K792350 CENTRIA LH RIA Union Carbide Corp. CEP Class I 1980-01-16
K792657 SENSI-SLIDE Hoffmann-La Roche, Inc. JHJ Class II 1980-01-16
K792554 ELVI MUCAPROTEINS Volu Sol Medical Industries JQN Class I 1980-01-16
K792557 SPECTROPHATOMETER MODELS 2280 & 2380AA The Perkin-Elmer Corp. JXR Class I 1980-01-16
K792539 TRIIODOTHYRONINE RIA SYSTEM Radioimmunoassay, Inc. CDP Class II 1980-01-16
K792524 CK-MB (CREATINE KINASE-MB) RIA CONTROL Mallinckrodt Critical Care JJX Class I 1980-01-16
K792532 GLUCOSE (HEXOKINASE) REAGENT SET Macomb Chemical Co. CFR Class II 1980-01-11
K792482 CHEMISTRY ANALYZER REAGENTS Laboratory Products, Inc. CIX Class II 1980-01-11
K792533 CREATINE PHOSPHOKINASE (CPK) REAGENT SET Macomb Chemical Co. JHW Class II 1980-01-11
K792531 SANDARE CHLORIDE PROCEDURE Sandare Chemical Co., Inc. CHJ Class II 1980-01-11
K792509 ACA HIGH DENSITY LIPOPROTEIN CHOLES. E.I. Dupont DE Nemours & Co., Inc. CHH Class I 1980-01-11
K792487 SERACON-SRII Bhp Diagnostix, Inc. JIX Class II 1979-12-31
K792486 SERACON-SRI (PROD. # D029 Bhp Diagnostix, Inc. JIX Class II 1979-12-31
K792230 AVL MODEL 940 AUTOMATIC PH/BLOOD GAS Gauntlet Technology Corp. CHL Class II 1979-12-31
K792485 SERACON-SRI Bhp Diagnostix, Inc. JIX Class II 1979-12-31
K792480 CHEM-STRATE TRIGLYCERIDE General Diagnostics CDT Class I 1979-12-27
K792477 CHEM-STRATE CK-NAC General Diagnostics CGS Class II 1979-12-27
K792443 TSH RADIOIMMUNOASSAY Dade, Baxter Travenol Diagnostics, Inc. JLW Class II 1979-12-27
K792478 CHEM-STRATE CHOLESTEROL General Diagnostics CHH Class I 1979-12-27
K792479 CHEM-STRATE AMYLASE General Diagnostics CIJ Class II 1979-12-27
K792447 REFEREE BFT BLOOD FOR TONOMETRY Analytical Products, Inc. JJS Class I 1979-12-27
K792484 TIPSEP-T3U TRIIODOTHYRONINE UPTAKE Nuclear Diagnostics, Inc. KHQ Class II 1979-12-27
K792361 SYSTEM 103 CHEMISTRY ANALYZER Gilford Instrument Laboratories, Inc. JJE Class I 1979-12-27
K792465 CONNECTICUT DIAGNOSTICS, LTS. DIRECT Connecticut Diagnostics, Ltd. CIG Class II 1979-12-18
K792328 STATTEK BUN Boehringer Mannheim Corp. CDN Class II 1979-12-18
K792289 LIPASE TEST KIT Mallinckrodt Critical Care CET Class I 1979-12-18
K792059 S.F.-P.A.P. TEST COUNTER IMMUNOELECTRO S.F. Biologicals, Inc. JFH Class II 1979-12-13
K792414 ELVI TRIGLYCERIDE Volu Sol Medical Industries JGY Class I 1979-12-07
K792404 ELVI CREATININE Volu Sol Medical Industries CGX Class II 1979-12-07
K792403 ELVI URIC ACID-COLORIMETRIC METHOD Volu Sol Medical Industries CDH Class I 1979-12-07
K792412 ELVI URIC ACID Volu Sol Medical Industries CDH Class I 1979-12-07
K792401 ELVI INORGANIC PHOSPHOROUS Volu Sol Medical Industries CEO Class I 1979-12-07
K792406 ELVI SERUM IRON Volu Sol Medical Industries CFM Class I 1979-12-07
K792400 ELVI CHLORIDE Volu Sol Medical Industries CHJ Class II 1979-12-07
K792397 ELVI CREATININE Volu Sol Medical Industries CGX Class II 1979-12-07
K792413 ELVI ALKALINE PHOSPHATATASE Volu Sol Medical Industries CJE Class II 1979-12-07
K792398 ELVI GLUCOSE Volu Sol Medical Industries CGA Class II 1979-12-07
K792313 CHOL-HDL TEST, HIGH LIPO. CHOL TEST Sclavo, Inc. LBR Class I 1979-12-07
K792402 ELVI CREATININ Volu Sol Medical Industries CGX Class II 1979-12-07
K792405 ELVI ACID & PROSTATIC PHOSPHATASE Volu Sol Medical Industries JFH Class II 1979-12-07
K792399 ELVI MAGNESIUM Volu Sol Medical Industries JGJ Class I 1979-12-07
K792415 ELVI TOTAL BILIRUBIN & FRACTIONS Volu Sol Medical Industries CIG Class II 1979-12-07
K792416 ELVI TOTAL PROTEINS Volu Sol Medical Industries CER Class II 1979-12-07
K792417 ELVI BLOOD UREA NITROGEN Volu Sol Medical Industries CDL Class II 1979-12-07
K792340 CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE Connecticut Diagnostics, Ltd. CEK Class II 1979-12-06
K792319 COULTER HDL CHOLESTEROL REAG. SYSTEM Coulter Electronics, Inc. LBS Class I 1979-12-06

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