ROCHE COBAS READY HDL CHOLESTEROL REAGENT

ROCHE COBAS READY HDL CHOLESTEROL REAGENT is an FDA 510(k)-cleared medical device (K902935) 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 September 26, 1990. Regulation: 8.