K-number	K180438
Device name	BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Applicant	Bd
Product code	PSZ
Device class	Class II
Decision date	Mar 20, 2018
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

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