K-number	K052264
Device name	QUANTA LITE CCP3 IGG ELISA
Applicant	Inova Diagnostics, Inc.
Product code	NHX
Device class	Class II
Decision date	Nov 23, 2005
Decision	Substantially Equivalent
Regulation	866.5775

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View the full FDA submission: accessdata.fda.gov

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QUANTA LITE CCP3 IGG ELISA

Everything you need for a 510(k) submission. Nothing you don't.