
Instrumentation Laboratory CO
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HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 is an FDA 510(k)-cleared medical device (K040359) 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 March 18, 2004. Regulation: 8.