Bruker Scientific L L C

FDA Filings

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

Bruker Scientific L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3003961381
FEI Number3003961381
NameBRUKER SCIENTIFIC LLC
Owner & OperatorBruker Scientific LLC
Contact Address40 Manning Road
Billerica MA 01821 US
Official Correspondent
  • David Cromwick
  • 1-978-6633660-1339
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address40 Manning Rd
Billerica, MA 01821 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



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 SCIENTIFIC LLC
MBT smart CA System2017-11-06
BRUKER SCIENTIFIC LLC
MBT sirius CA System2017-11-06
BRUKER SCIENTIFIC LLC
MALDI Biotyper sirius CA System2017-11-06
BRUKER SCIENTIFIC LLC
MALDI Biotyper MBT smart CA System2017-11-06
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 SCIENTIFIC LLC
MBT smart CA System2016-06-01
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
BRUKER SCIENTIFIC LLC
US IVD HCCA2013-12-12
BRUKER SCIENTIFIC LLC
US IVD BTS2013-12-12
BRUKER SCIENTIFIC LLC
MBT-CA System2013-12-12
BRUKER SCIENTIFIC LLC
MALDI Biotyper CA System2013-12-12
BRUKER SCIENTIFIC LLC
BD Bruker MBT-CA System2013-12-12
BRUKER SCIENTIFIC LLC
BD Bruker MALDI Biotyper CA System2013-12-12

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