K-number	K152612
Device name	eSensor Warfarin Sensitivity Saliva Test
Applicant	Genmark Diagnostics, Incorporated
Product code	ODW
Device class	Class II
Decision date	May 26, 2016
Decision	Substantially Equivalent
Regulation	862.3360

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Source

View the full FDA submission: accessdata.fda.gov

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eSensor Warfarin Sensitivity Saliva Test

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