K-number	K110786
Device name	ESENSOR WARFARIN SENSITIVITY SALIVA TEST
Applicant	GenMark Diagnostics, Inc.
Product code	NSU
Device class	Class II
Decision date	Dec 2, 2011
Decision	Substantially Equivalent
Regulation	862.2570

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View the full FDA submission: accessdata.fda.gov

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ESENSOR WARFARIN SENSITIVITY SALIVA TEST

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