K-number	K172722
Device name	Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Applicant	Euroimmun Us, Inc.
Product code	LSR
Device class	Class II
Decision date	Dec 10, 2017
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

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