ADVIA CHEMISTRY TOTAL BILIRUBIN_2

ADVIA CHEMISTRY TOTAL BILIRUBIN_2 is an FDA 510(k)-cleared medical device (K063845) manufactured by Bayer Healthcare, LLC. 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 December 6, 2007. Regulation: 8.