COAGULATION CONTROL LEVEL 3 (ABNORMAL)

COAGULATION CONTROL LEVEL 3 (ABNORMAL) is an FDA 510(k)-cleared medical device (K984131) 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 November 30, 1998. Regulation: 8.