PROTHROMBIN FREE BEEF PLASMA (PFB)

PROTHROMBIN FREE BEEF PLASMA (PFB) is an FDA 510(k)-cleared medical device (K791023) manufactured by Pacific Hemostasis. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 1979. Regulation: 8.