K-number	K070804
Device name	VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
Applicant	Nanosphere, Inc.
Product code	ODW
Device class	Class II
Decision date	Sep 17, 2007
Decision	Substantially Equivalent
Regulation	862.3360

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VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST

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