DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET

DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET is an FDA 510(k)-cleared medical device (K112120) manufactured by Diazyme Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2013. Regulation: 8.