HEMOSIL F11 & FV DNA CONTROL

HEMOSIL F11 & FV DNA CONTROL is an FDA 510(k)-cleared medical device (K093737) manufactured by Instrumentation Laboratory CO. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 2010. Regulation: 8.