K-number	K163713
Device name	Sofia Lyme FIA, Sofia Lyme Control Set
Applicant	Quidel Corporation
Product code	LSR
Device class	Class II
Decision date	Oct 20, 2017
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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Sofia Lyme FIA, Sofia Lyme Control Set

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