K-number	K173496
Device name	Sofia 2 Lyme FIA, Sofia Lyme Control Set
Applicant	Quidel Corporation
Product code	LSR
Device class	Class II
Decision date	Aug 30, 2018
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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Sofia 2 Lyme FIA, Sofia Lyme Control Set

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