HEMOSIL HIGH ABNORMAL CONTROL ASSAYED

HEMOSIL HIGH ABNORMAL CONTROL ASSAYED is an FDA 510(k)-cleared medical device (K021024) 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 May 15, 2002. Regulation: 8.