Bruker Daltonik GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K193419MBT SepsityperDecember 27, 2020
DEN170081MALDI Biotyper CA SystemApril 20, 2018
K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemJuly 26, 2017