K-number	K163695
Device name	Borrelia B31 ViraChip IgM Test Kit
Applicant	Viramed Biotech AG
Product code	LSR
Device class	Class II
Decision date	Aug 22, 2017
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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Borrelia B31 ViraChip IgM Test Kit

Everything you need for a 510(k) submission. Nothing you don't.