IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) is an FDA 510(k)-cleared medical device (K870354) 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 February 9, 1987. Regulation: 8.