FACTOR VIII DEFICIENT PLASMA #B8D

FACTOR VIII DEFICIENT PLASMA #B8D is an FDA 510(k)-cleared medical device (K812431) manufactured by Sigma Chemical 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 September 22, 1981. Regulation: 8.