MBT Compass HT CA Software; MBT FAST Shuttle US IVD— 510(k) K251495
Substantially EquivalentBruker Daltonics GmbH & Co. KG
FDA 510(k) clearance K251495 for MBT Compass HT CA Software; MBT FAST Shuttle US IVD, Substantially Equivalent on 2025-08-13. Applicant: Bruker Daltonics GmbH & Co. KG.
Clearance details
- Applicant
- Bruker Daltonics GmbH & Co. KG
- Product code
- Code QBN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bremen, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.