ROCHE REAGENT FOR URIC ACID--MODIFICATION

ROCHE REAGENT FOR URIC ACID--MODIFICATION is an FDA 510(k)-cleared medical device (K922762) 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 July 8, 1992. Regulation: 8.