FDA.reportPublic FDA data

Bruker Daltonics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101917493010191749Bruker Daltonics1N2026-01-01Fahrenheitstrasse 4 Bremen DE 28359

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2004491652299481K251495MBT Compass HT CA Software; MBT FAST Shuttle US IVDQBN2025-08-13
2004492028273627K193419MBT SepsityperQNJ2020-12-27
2004491331896078K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemPEX2017-07-26
2004491707395324K142677MALDI Biotyper CA SystemPEX2015-03-27
2004491589066761K130831MALDI BIOTYPER CA (MBT-CA) SYSTEMPEX2013-11-21
2004491294443498
2004491575012347

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PEX32017-07-26
QBN12025-08-13
QNJ12020-12-27