BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280)
Description
BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App by Bd Kiestra B.V., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213280
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 Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (K213280) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Modu... | Clever Culture Systems | 2021 |
Trace the full predicate network for K213280
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.