MBT Compass HT CA Software; MBT FAST Shuttle US IVD— 510(k) K251495

Name: FDA 510(k) clearance K251495
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Substantially Equivalent

Bruker 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. Device class: 2.

Clearance details

Applicant: Bruker Daltonics GmbH & Co. KG
Product code: Code QBN
Device class: Class 2
Regulation: 21 CFR 866.3378
Advisory panel: Microbiology
Date received: 2025-05-15
Decision date: 2025-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

Download summary PDF View on FDA.gov ↗

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