K-number	K061842
Device name	QUANTA LITE PBC SCREEN IGG/IGA ELISA
Applicant	Inova Diagnostics, Inc.
Product code	NRI
Device class	Class II
Decision date	Oct 18, 2006
Decision	Substantially Equivalent
Regulation	866.5090

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View the full FDA submission: accessdata.fda.gov

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QUANTA LITE PBC SCREEN IGG/IGA ELISA

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