
Miles, Inc.
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TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 is an FDA 510(k)-cleared medical device (K933478) manufactured by Miles, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1993. Regulation: 8.