Medical Device Manufacturer · DE , Bremen

Bruker Daltonik GmbH - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2017
3
Total
2
Cleared
1
Denied

FDA 510(k) cleared devices by Bruker Daltonik GmbH Microbiology ✕

3 devices
1-3 of 3
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · QNJ
Microbiology · 384d
Not Cleared Apr 20, 2018
MALDI Biotyper CA System
DEN170081 · QBN
Microbiology · 203d
Cleared Jul 26, 2017
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536 · PEX
Microbiology · 222d
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