K-number	K050715
Device name	QUANTA PLEX ANCA PROFILE
Applicant	Inova Diagnostics, Inc.
Product code	MOB
Device class	Class II
Decision date	May 12, 2005
Decision	Substantially Equivalent
Regulation	866.5660

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View the full FDA submission: accessdata.fda.gov

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QUANTA PLEX ANCA PROFILE

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