MBT Sepsityper

System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Bruker Daltonik GmbH

The following data is part of a premarket notification filed by Bruker Daltonik Gmbh with the FDA for Mbt Sepsityper.

Pre-market Notification Details

Device IDK193419
510k NumberK193419
Device Name:MBT Sepsityper
ClassificationSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Applicant Bruker Daltonik GmbH Fahrenheitstrasse 4 Bremen,  DE 28359
ContactPeter Trinder
CorrespondentPeter Trinder
Bruker Daltonik GmbH Fahrenheitstrasse 4 Bremen,  DE 28359
Product CodePEX  
CFR Regulation Number866.3361 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-12-27

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