K-number	K161513
Device name	Anti-Borrelia burgdorferi US Westernblot (IgG)
Applicant	Euroimmun US
Product code	LSR
Device class	Class II
Decision date	Aug 25, 2016
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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Anti-Borrelia burgdorferi US Westernblot (IgG)

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