510(k) K251495 ยท QBN Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
MBT Compass HT CA Software; MBT FAST Shuttle US IVD
| Applicant | Bruker Daltonics GmbH & Co. KG, Bremen, DE |
| Decision | Substantially Equivalent, Aug 13, 2025 |
| Received | May 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251495
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.