I-STAT PROTHROMBIN TIME TEST

I-STAT PROTHROMBIN TIME TEST is an FDA 510(k)-cleared medical device (K020355) manufactured by I-Stat Corporation. 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 13, 2002. Regulation: 8.