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Bayer Healthcare, LLC
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MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM is an FDA 510(k)-cleared medical device (K051693) manufactured by Bayer Healthcare, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2005. Regulation: 8.