ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)

ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) is an FDA 510(k)-cleared medical device (K895260) 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 October 5, 1989. Regulation: 8.