K-number	K101514
Device name	BD DIRECTIGEN EZ RSV
Applicant	Becton, Dickinson & CO
Product code	GQG
Device class	Class I
Decision date	Jul 9, 2010
Decision	Substantially Equivalent
Regulation	866.3480

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View the full FDA submission: accessdata.fda.gov

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BD DIRECTIGEN EZ RSV

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