BIOMERIEUX HEMOLAB FIBRINOMAT

BIOMERIEUX HEMOLAB FIBRINOMAT is an FDA 510(k)-cleared medical device (K925494) manufactured by Biomerieux Vitek, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 1993. Regulation: 8.