THROMBIN CLOT TIME TEST PROCEDURE

THROMBIN CLOT TIME TEST PROCEDURE is an FDA 510(k)-cleared medical device (K923220) manufactured by Medical Laboratory Automation Systems, 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 September 28, 1992. Regulation: 8.