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Fujirebio Diagnostics,Inc.
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FUJIREBIO DIAGNOSTICS CA 19-9 RIA is an FDA 510(k)-cleared medical device (K020566) manufactured by Fujirebio 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 May 8, 2002. Regulation: 8.