K-number	K181029
Device name	Solana Bordetella Complete Assay
Applicant	Quidel Corporation
Product code	OZZ
Device class	Class II
Decision date	Jul 15, 2018
Decision	Substantially Equivalent
Regulation	866.3980

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View the full FDA submission: accessdata.fda.gov

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Solana Bordetella Complete Assay

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