K-number	K162274
Device name	Solana Strep Complete Assay
Applicant	Quidel Corporation
Product code	PGX
Device class	Class II
Decision date	Oct 25, 2016
Decision	Substantially Equivalent
Regulation	866.2680

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Source

View the full FDA submission: accessdata.fda.gov

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Solana Strep Complete Assay

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