Medical Device Manufacturer · DE , Bremen

Bruker Daltonik GmbH - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2017

Recent clearances: MBT Sepsityper, MALDI Biotyper CA (MBT-CA) System, MBT smart CA System

View 3 510(k) Devices ↓

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Bruker Daltonik GmbH Microbiology ✕

3 devices

1-3 of 3

Cleared Dec 27, 2020

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

Microbiology · 222d