K-number	K131185
Device name	ANA SCREEN ELISA (IGG)
Applicant	Euroimmun US
Product code	LJM
Device class	Class II
Decision date	Jul 15, 2013
Decision	Substantially Equivalent
Regulation	866.5100

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Source

View the full FDA submission: accessdata.fda.gov

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ANA SCREEN ELISA (IGG)

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