BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV

Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Veritor System For The Rapid Detection Of Rsv.

Pre-market Notification Details

Device IDK133140
510k NumberK133140
Device Name:BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
ClassificationAntigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Applicant BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego,  CA  92121
ContactGregory P Payne
CorrespondentGregory P Payne
BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego,  CA  92121
Product CodeGQG  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2013-11-15
Summary:summary

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