
Bayer Corp.
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ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS is an FDA 510(k)-cleared medical device (K012777) manufactured by Bayer 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 October 21, 2001. Regulation: 8.