COAGULATION INTRINSIC DEFICIENT PLASMAS

COAGULATION INTRINSIC DEFICIENT PLASMAS is an FDA 510(k)-cleared medical device (K864481) manufactured by Instrumentation Laboratory 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 January 4, 1987. Regulation: 8.