ADVIA 60 HEMATOLOGY ANALYZER

ADVIA 60 HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K032524) 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 September 7, 2003. Regulation: 8.