MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495)
Description
MBT Compass HT CA Software; MBT FAST Shuttle US IVD by Bruker Daltonics GmbH & Co. KG, an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251495
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. MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193419 | MBT Sepsityper | Bruker Daltonik GmbH | 2020 |
Trace the full predicate network for K251495
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.