
International Technidyne Corp.
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HEMOCHRON ONESTEP APTT TEST is an FDA 510(k)-cleared medical device (K915344) 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 February 10, 1992. Regulation: 8.