Name: Predicase
Price: 199 USD

K-number	K882629
Device name	DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GQG
Device class	Class I
Decision date	Oct 31, 1988
Decision	Substantially Equivalent
Regulation	866.3480

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Source

View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT

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