K-number	K113847
Device name	BORRELIA BURGDORFERI IGG BLOT TEST
Applicant	Gold Standard Diagnostics
Product code	LSR
Device class	Class II
Decision date	Apr 11, 2012
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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BORRELIA BURGDORFERI IGG BLOT TEST

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