K-number	K162438
Device name	Sofia Influenza A+B FIA on Sofia 2
Applicant	Quidel Corporation
Product code	PSZ
Device class	Class II
Decision date	Apr 14, 2017
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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Sofia Influenza A+B FIA on Sofia 2

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