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Instrumentation Laboratory CO
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HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL is an FDA 510(k)-cleared medical device (K113211) 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 January 3, 2012. Regulation: 8.