K-number	K101529
Device name	BD DIRECTIGEN EZ FLU A+B ASSAY
Applicant	Becton, Dickinson & CO
Product code	PSZ
Device class	Class II
Decision date	Jun 14, 2010
Decision	Substantially Equivalent
Regulation	866.3328

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Source

View the full FDA submission: accessdata.fda.gov

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BD DIRECTIGEN EZ FLU A+B ASSAY

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