PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION is an FDA 510(k)-cleared medical device (K911995) 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 July 16, 1991. Regulation: 8.