COBAS READY PROFILE 2 REAGENT STRIP

COBAS READY PROFILE 2 REAGENT STRIP is an FDA 510(k)-cleared medical device (K896225) 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 June 25, 1990. Regulation: 8.