
Bayer Diagnostics Corp.
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ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD is an FDA 510(k)-cleared medical device (K022668) manufactured by Bayer Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2002. Regulation: 8.