FDA.reportPublic FDA data

510(k) K163536

Device
MALDI Biotyper CA (MBT-CA) System, MBT Smart CA System
Applicant
BRUKER DALTONIK GMBH
510(k) number
K163536
Product code
PEX  
Decision
Substantially Equivalent (SESE)
Decision date
2017-07-26
Date received
2016-12-16
Regulation
866.3361
Classification name
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARKUS KOSTRZEWA
Address
Fahrenheitstrasse 4 Bremen DE 28359 28359

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PEX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162950VITEK MSbioMerieux, Inc.2017-07-22
K142677MALDI Biotyper CA SystemBruker Daltonics, Inc.2015-03-27
K130831MALDI BIOTYPER CA (MBT-CA) SYSTEMBruker Daltonics, Inc.2013-11-21
DEN130013VITEK MSbioMerieux, Inc.2013-08-21

Legacy Summary#

summary

FDA Review#

Decision Summary