REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- is an FDA 510(k)-cleared medical device (K800689) manufactured by Diagnostic Solutions, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 29, 1980. Regulation: 8.