ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT is an FDA 510(k)-cleared medical device (K073720) manufactured by Osmetech Molecular Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2008. Regulation: 8.