ADVIA Centaur CA 15-3 assay

ADVIA Centaur CA 15-3 assay is an FDA 510(k)-cleared medical device (K192777) 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 November 21, 2019. Regulation: 8.