K-number	K162911
Device name	Sofia RSV FIA on Sofia 2 analyzer
Applicant	Quidel Corporation
Product code	GQG
Device class	Class I
Decision date	Feb 22, 2017
Decision	Substantially Equivalent
Regulation	866.3480

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Source

View the full FDA submission: accessdata.fda.gov

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Sofia RSV FIA on Sofia 2 analyzer

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