STAGO FACTOR XII-DEFICIENT PLASMA

STAGO FACTOR XII-DEFICIENT PLASMA is an FDA 510(k)-cleared medical device (K933438) manufactured by American Bioproducts 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 October 26, 1993. Regulation: 8.