HITT BY HEMOCHRON(R)

HITT BY HEMOCHRON(R) is an FDA 510(k)-cleared medical device (K910181) 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 9, 1991. Regulation: 8.