K-number	K161258
Device name	NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
Applicant	Inova Diagnostics, Inc.
Product code	MOB
Device class	Class II
Decision date	Feb 3, 2017
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

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