HEMOSIL FACTOR IX DEFICIENT PLASMA

HEMOSIL FACTOR IX DEFICIENT PLASMA is an FDA 510(k)-cleared medical device (K031829) manufactured by Instrumentation Laboratory CO. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2003. Regulation: 8.