INNOVANCE D-DIMER, MODEL OPBP09

INNOVANCE D-DIMER, MODEL OPBP09 is an FDA 510(k)-cleared medical device (K091916) 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 October 28, 2009. Regulation: 8.