Class Class II
BD Vaginal Panel (K223653)
Description
BD Vaginal Panel by Becton, Dickinson and Company, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223653
Clearance Date2023-03-06
Clearance TypeTraditional
Product CodePQA
Regulation Number866.3975
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223653
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 Vaginal Panel (K223653) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Coll... | Geneohm Sciences Canada, Inc. (Bd L... | 2021 |
| K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd D... | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024 |
Trace the full predicate network for K223653
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.