Bruker Daltonik

FDA Filings

This page includes the latest FDA filings for Bruker Daltonik. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010191749
FEI Number3010191749
NameBruker Daltonik
Owner & OperatorBruker Scientific LLC
Contact Address40 Manning Road
Billerica MA 01821 US
Official Correspondent
  • David Cromwick
  • 1-978-6633660-1339
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFahrenheitstrasse 4
Bremen Bremen, 28359 DE
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Bruker Daltonik [Bruker Scientific LLC]
MBT smart CA System2017-11-06
Bruker Daltonik [Bruker Scientific LLC]
MBT sirius CA System2017-11-06
Bruker Daltonik [Bruker Scientific LLC]
MALDI Biotyper sirius CA System2017-11-06
Bruker Daltonik [Bruker Scientific LLC]
MALDI Biotyper MBT smart CA System2017-11-06
Bruker Daltonik [Bruker Scientific LLC]
MALDI Biotyper MBT CA System2017-11-06
Bruker Daltonik [Bruker Scientific LLC]
MBT Pilot2016-12-12
Bruker Daltonik [Bruker Scientific LLC]
MBT Pilot System2016-12-12
Bruker Daltonik [Bruker Scientific LLC]
MBT Galaxy2016-12-12
Bruker Daltonik [Bruker Scientific LLC]
MBT Galaxy System2016-12-12
Bruker Daltonik [Bruker Scientific LLC]
MBT smart CA System2016-06-01
Bruker Daltonik [Bruker Scientific LLC]
MALDI Biotyper MBT Smart CA System2016-06-01
Bruker Daltonik [Bruker Scientific LLC]
US IVD HCCA2013-12-12
Bruker Daltonik [Bruker Scientific LLC]
US IVD BTS2013-12-12
Bruker Daltonik [Bruker Scientific LLC]
MBT-CA System2013-12-12
Bruker Daltonik [Bruker Scientific LLC]
MALDI Biotyper CA System2013-12-12
Bruker Daltonik [Bruker Scientific LLC]
BD Bruker MBT-CA System2013-12-12
Bruker Daltonik [Bruker Scientific LLC]
BD Bruker MALDI Biotyper CA System2013-12-12

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