Source document or public record
FDA 510(k) K251495 — MBT Compass HT CA Software; MBT FAST Shuttle US IVD
FDA 510(k) index record K251495. Device: MBT Compass HT CA Software; MBT FAST Shuttle US IVD. Applicant as listed: Bruker Daltonics GmbH & Co. KG. Decision date: 2025-08-13.
Source
"device_name": "MBT Compass HT CA Software; MBT FAST Shuttle US IVD"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251495.
Device name: MBT Compass HT CA Software; MBT FAST Shuttle US IVD. Applicant as listed: Bruker Daltonics GmbH & Co. KG.
Decision date: 2025-08-13. Decision wording: Substantially Equivalent.
Product code: QBN. Regulation: 21 CFR 866.3378. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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