COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA

COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA is an FDA 510(k)-cleared medical device (K853461) manufactured by American Dade. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 1985. Regulation: 8.