HELENA FACTOR II DEFICIENT SUB. PLASMA

HELENA FACTOR II DEFICIENT SUB. PLASMA is an FDA 510(k)-cleared medical device (K792336) manufactured by Helena Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 1979. Regulation: 8.