BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

Devices Detecting Influenza A, B, And C Virus Antigens

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Veritor System For The Rapid Detection Of Flu A+b.

Pre-market Notification Details

Device IDK120049
510k NumberK120049
Device Name:BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant Becton, Dickinson And Company 10865 ROAD TO THE CURE, SUITE 200 San Diego,  CA  92064
ContactGregory P Payne
CorrespondentGregory P Payne
Becton, Dickinson And Company 10865 ROAD TO THE CURE, SUITE 200 San Diego,  CA  92064
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-06
Decision Date2012-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902560418 K120049 000

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