Xprecia Stride Coagulation System, Xprecia System PT Controls

Xprecia Stride Coagulation System, Xprecia System PT Controls is an FDA 510(k)-cleared medical device (K151964) 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 September 29, 2016. Regulation: 8.