Name: Predicase
Price: 199 USD

K-number	K152870
Device name	BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
Applicant	Becton, Dickinson and Co.
Product code	PSZ
Device class	Class II
Decision date	Oct 27, 2015
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 the Rapid Detection of Flu A + B CLIA waived kit

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