FDA 510(k) Applications for Medical Device Product Code "CIS"
(Hydrazone Colorimetry, Ast/Sgot)

FDA 510(k) Number Applicant Device Name Decision Date
K032027 CHOLESTECH CORP. CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) 09/05/2003
K854187 CLINICAL DATA, INC. IN-VITRO TEST DETERMINATION OF SGOT (AST) 11/25/1985
K812872 INSTRUMENTATION LABORATORY CO. OPTIONAL TOTAL CA-MODULE FOR IL 504/508 10/26/1981
K896238 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY AST REAGENT 02/16/1990
K792410 VOLU SOL MEDICAL INDUSTRIES ELVI SGOT & SGPT TRANSAMINASE 12/06/1979


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