K251495
- 510(k) number
- K251495
- Device name
- MBT Compass HT CA Software; MBT FAST Shuttle US IVD
- Applicant
- Bruker Daltonics GmbH & Co. KG DE
- Product code
- QBN — Mass Spectrometry, Maldi Tof, Microorganism Identifi
- Decision date
- 2025-08-13
- Date received
- 2025-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251495.pdf
Official FDA record: K251495
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.