K-number	K001364
Device name	BD DIRECTIGEN FLU A+B
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	PSZ
Device class	Class II
Decision date	Jun 28, 2000
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 FLU A+B

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