CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS)

CRS FIBRIN ANALYSIS CATHETER TESTING SYSTEM (FACTS) is an FDA 510(k)-cleared medical device (K072518) manufactured by Crs Medical Diagnostics, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2007. Regulation: 8.