K-number	K142038
Device name	EUROIMMUN LYME ELISA(IgG/IgM)
Applicant	Euroimmun US
Product code	LSR
Device class	Class II
Decision date	May 4, 2015
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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EUROIMMUN LYME ELISA(IgG/IgM)

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