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Bayer Diagnostics Corp.
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CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM is an FDA 510(k)-cleared medical device (K022329) manufactured by Bayer Diagnostics Corp.. 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 26, 2002. Regulation: 8.