510(k) K251495

Device

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Applicant

Bruker Daltonics GmbH & Co. KG

510(k) number

K251495

Product code

QBN

Decision

Substantially Equivalent (SESE)

Decision date

2025-08-13

Date received

2025-05-15

Regulation

866.3378

Classification name

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No