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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) 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. The listed applicant is Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.

When did MBT Compass HT CA Software; MBT FAST Shuttle US IVD receive FDA 510(k) clearance?

MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251495.

Who is the listed applicant for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

The FDA 510(k) record lists Bruker Daltonics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212461VITEK MS PRIMEbioMerieux, Inc.K181412VITEK MSbioMerieux, Inc.

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.

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