
International Technidyne Corp.
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MICROCOAGULATION PROTHROMBIN TIME TEST is an FDA 510(k)-cleared medical device (K940432) 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 May 17, 1994. Regulation: 8.