
Instrumentation Laboratory CO
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HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is an FDA 510(k)-cleared medical device (K153137) manufactured by Instrumentation Laboratory CO. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2016. Regulation: 8.