BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived Kit

Devices Detecting Influenza A, B, And C Virus Antigens

BD

The following data is part of a premarket notification filed by Bd with the FDA for Bd Veritor System For Rapid Detection Of Flu A + B Clia Waived Kit.

Pre-market Notification Details

Device IDK180438
510k NumberK180438
Device Name:BD Veritor System For Rapid Detection Of Flu A + B CLIA Waived Kit
ClassificationDevices Detecting Influenza A, B, And C Virus Antigens
Applicant BD 10865 Road To The Cure San Diego,  CA  92121
ContactBrad Spring
CorrespondentMary Ann Fiechtner
BD 10865 Road To The Cure Suite 200 San Diego,  CA  92121
Product CodePSZ  
CFR Regulation Number866.3328 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-20
Decision Date2018-03-20
Summary:summary

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