BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016)
Description
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit by Bd, an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223016
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (K223016) cites 6 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA wai... | Bd | 2018 |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA wai... | Becton, Dickinson & CO | 2016 |
| K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015 |
| K132692 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013 |
| K132259 | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2013 |
| K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B | Becton, Dickinson and Company | 2011 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232434 | BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waiv... | Bd | 2023 |
Trace the full predicate network for K223016
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.