K-number	K993294
Device name	DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
Applicant	Diamedix Corp.
Product code	LKJ
Device class	Class II
Decision date	Oct 25, 1999
Decision	Substantially Equivalent
Regulation	866.5100

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View the full FDA submission: accessdata.fda.gov

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DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM

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