MBT Compass HT CA Software; MBT FAST Shuttle US IVD
K-Number: K251495 · 2025-08-13
ApplicantBruker Daltonics GmbH & Co. KG
Decision Date2025-08-13
Product CodeQBN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device manufactured by Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under approval number K251495. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device that received FDA 510(k) clearance on 2025-08-13. It is manufactured by Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.
When was MBT Compass HT CA Software; MBT FAST Shuttle US IVD approved by the FDA?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under approval number K251495.
What company makes MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
MBT Compass HT CA Software; MBT FAST Shuttle US IVD is manufactured by Bruker Daltonics GmbH & Co. KG.
What is the FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?
The FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD is QBN.
Related Devices (Code: QBN)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.