K-number	K123197
Device name	VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
Applicant	Nanosphere, Inc.
Product code	OZN
Device class	Class II
Decision date	Dec 5, 2012
Decision	Substantially Equivalent
Regulation	866.3130

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View the full FDA submission: accessdata.fda.gov

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VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

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