COAGULATION REFERENCE PLASMA, NORMAL

COAGULATION REFERENCE PLASMA, NORMAL is an FDA 510(k)-cleared medical device (K905203) manufactured by Medical Diagnostic Technologies, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 1990. Regulation: 8.