ADVIA Centaur CA 125II

ADVIA Centaur CA 125II is an FDA 510(k)-cleared medical device (K200199) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2020. Regulation: 8.