
GenMark Diagnostics, Inc.
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ESENSOR WARFARIN SENSITIVITY SALIVA TEST is an FDA 510(k)-cleared medical device (K110786) manufactured by GenMark Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2011. Regulation: 8.