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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
510(k) Number K251495
Device Name MBT Compass HT CA Software; MBT FAST Shuttle US IVD
Applicant
Bruker Daltonics GmbH & Co. KG
Fahrenheitstraße 4
Bremen,  DE 28359
Applicant Contact Kirsten Webner
Correspondent
Bruker Daltonics GmbH & Co. KG
Fahrenheitstraße 4
Bremen,  DE 28359
Correspondent Contact Kirsten Webner
Classification Product Code
QBN  
Date Received05/15/2025
Decision Date 08/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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