STRATUS CS ACUTE CARE D-DIMER

STRATUS CS ACUTE CARE D-DIMER is an FDA 510(k)-cleared medical device (K110303) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 15, 2011. Regulation: 8.