K-number	K110203
Device name	XPERT C. DIFFICLE/EPI ASSAY
Applicant	Cepheid
Product code	OMN
Device class	Class I
Decision date	Apr 7, 2011
Decision	Substantially Equivalent
Regulation	866.2660

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Source

View the full FDA submission: accessdata.fda.gov

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XPERT C. DIFFICLE/EPI ASSAY

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