K-number	K073720
Device name	ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
Applicant	Osmetech Molecular Diagnostics
Product code	ODW
Device class	Class II
Decision date	Jul 17, 2008
Decision	Substantially Equivalent
Regulation	862.3360

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View the full FDA submission: accessdata.fda.gov

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ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

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