ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL

ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL is an FDA 510(k)-cleared medical device (K900120) manufactured by Roche Diagnostic Systems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 8, 1990. Regulation: 8.