INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 is an FDA 510(k)-cleared medical device (K081769) 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 27, 2009. Regulation: 8.