K-number	K926562
Device name	QUANTA LITE(TM) JO-1 ELISA KIT
Applicant	Inova Diagnostics, Inc.
Product code	LLL
Device class	Class II
Decision date	Mar 4, 1993
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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QUANTA LITE(TM) JO-1 ELISA KIT

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