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Bruker Daltonik GmbH
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K193419
MBT Sepsityper
December 27, 2020
DEN170081
MALDI Biotyper CA System
April 20, 2018
K163536
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
July 26, 2017