PROTHROMBIN TIME (PT) BY HEMOCHRON

PROTHROMBIN TIME (PT) BY HEMOCHRON is an FDA 510(k)-cleared medical device (K893378) manufactured by International Technidyne Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 21, 1989. Regulation: 8.