COBAS INTEGRA 400/800 BILIRUBIN TOTAL

COBAS INTEGRA 400/800 BILIRUBIN TOTAL is an FDA 510(k)-cleared medical device (K081193) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2009. Regulation: 8.