BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER is an FDA 510(k)-cleared medical device (K032525) 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 September 8, 2003. Regulation: 8.