MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION is an FDA 510(k)-cleared medical device (K012286) manufactured by Roche Diagnostics Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 7, 2001. Regulation: 8.