FDA 510(k) Applications for Medical Device Product Code "CGE"
(Orthotoluidine, Glucose)

FDA 510(k) Number Applicant Device Name Decision Date
K890335 ALPKEM CORP. SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. 02/17/1989
K781308 ANALYTICAL & RESEARCH CHEMICALS, INC. GLUCOLOUR 08/31/1978
K810089 ANCO MEDICAL REAGENTS & ASSOC. 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI 01/26/1981
K850930 DILAB, INC. GLUCOSE 06/10/1985
K790319 FISHER SCIENTIFIC CO., LLC. ORTHO-TOLUIDINE REAGENT SET 03/21/1979
K771091 HARLECO UNIPAK GLUCOSE 07/21/1977
K770455 ICN PHARMACEUTICALS, INC. GLUCOSE PROCEDURE, TEKPOINT DIRECT 05/03/1977
K811883 KING DIAGNOSTICS, INC. KING DIAGNOSTICS GLUCOSE-O TEST 07/23/1981
K771314 MALLINCKRODT CRITICAL CARE GLUCOSE REAGENT (O-TOLUIDINE) 08/03/1977
K841054 MEDICAL SPECIALTIES, INC. DIRECT GLUCOSE REAGENT SET 05/01/1984
K821198 OMEGA MEDICAL ELECTRONICS DIRECT GLUCOSE REAGENT SET 07/13/1982
K855185 TECHNOSTICS INTL. GLUCOSE REAGENT SET 01/22/1986


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