HemosIL D-Dimer HS

HemosIL D-Dimer HS is an FDA 510(k)-cleared medical device (K160885) 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 October 26, 2016. Regulation: 8.