HemosIL D-Dimer HS 500

HemosIL D-Dimer HS 500 is an FDA 510(k)-cleared medical device (K172903) 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 November 21, 2017. Regulation: 8.