K-number	K110620
Device name	PREMIER C. DIFFICILE GDH
Applicant	Meridian Bioscience, Inc.
Product code	MCB
Device class	Class I
Decision date	May 3, 2011
Decision	Substantially Equivalent
Regulation	866.2660

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Source

View the full FDA submission: accessdata.fda.gov

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PREMIER C. DIFFICILE GDH

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