HEMOSIL FACTOR VIII DEFICIENT PLASMA

HEMOSIL FACTOR VIII DEFICIENT PLASMA is an FDA 510(k)-cleared medical device (K034007) 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 February 12, 2004. Regulation: 8.