HemosIL Silica Clotting Time

HemosIL Silica Clotting Time is an FDA 510(k)-cleared medical device (K160445) 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 15, 2016. Regulation: 8.