K-number	K132726
Device name	ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
Applicant	Primeradx
Product code	OZN
Device class	Class II
Decision date	Nov 29, 2013
Decision	Substantially Equivalent
Regulation	866.3130

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Source

View the full FDA submission: accessdata.fda.gov

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ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

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