K-number	K223016
Device name	BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
Applicant	Bd
Product code	PSZ
Device class	Class II
Decision date	Jan 27, 2023
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

Everything you need for a 510(k) submission. Nothing you don't.