FACTOR IX DEFICIENT PLASMA, B9D -

FACTOR IX DEFICIENT PLASMA, B9D - is an FDA 510(k)-cleared medical device (K843215) 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 November 18, 1984. Regulation: 8.