GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED is an FDA 510(k)-cleared medical device (K910108) manufactured by Gds Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 3, 1991. Regulation: 8.