MALDI Biotyper CA (MBT-CA) System, MBT Smart CA System

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 Maldi Biotyper Ca (mbt-ca) System, Mbt Smart Ca System.

Pre-market Notification Details

Device IDK163536
510k NumberK163536
Device Name:MALDI Biotyper CA (MBT-CA) System, MBT Smart CA System
ClassificationSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Applicant BRUKER DALTONIK GMBH FAHRENHEITSTRASSE 4 Bremen,  DE 28359
ContactMarkus Kostrzewa
CorrespondentDavid Cromwick
BRUKER DALTONICS, INC 40 MANNING ROAD Billerica,  MA  01821
Product CodePEX  
CFR Regulation Number866.3361 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-16
Decision Date2017-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04251204325772 K163536 000
04251204326168 K163536 000
04251204326359 K163536 000
04251204326311 K163536 000
04251204326175 K163536 000

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