
International Technidyne Corp.
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HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT is an FDA 510(k)-cleared medical device (K924638) 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 January 13, 1993. Regulation: 8.