K-number	DEN130032
Device name	XPERT MTB/RIF ASSAY
Applicant	Cepheid
Product code	PEU
Device class	Class II
Decision date	Jul 25, 2013
Decision	Not Substantially Equivalent
Regulation	866.3373

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Source

View the full FDA submission: accessdata.fda.gov

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XPERT MTB/RIF ASSAY

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