K-number	K173691
Device name	Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
Applicant	Quidel Corporation
Product code	LSR
Device class	Class II
Decision date	Feb 28, 2018
Decision	Substantially Equivalent
Regulation	866.3830

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Source

View the full FDA submission: accessdata.fda.gov

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Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

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