K-number	K101461
Device name	BD DIRECTIGEN EX FLU A+B
Applicant	Becton, Dickinson and Company
Product code	PSZ
Device class	Class II
Decision date	Jun 24, 2010
Decision	Substantially Equivalent
Regulation	866.3328

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View the full FDA submission: accessdata.fda.gov

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BD DIRECTIGEN EX FLU A+B

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