COAGULATION FACTOR DEFICIENT PLASMA

COAGULATION FACTOR DEFICIENT PLASMA is an FDA 510(k)-cleared medical device (K840114) manufactured by Medical Specialties 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 February 3, 1984. Regulation: 8.