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Bayer Healthcare, LLC
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BAYER ADVIA CENTAUR CA 19-9 ASSAY is an FDA 510(k)-cleared medical device (K031393) manufactured by Bayer Healthcare, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2003. Regulation: 8.