PEX · Class II · 21 CFR 866.3361

FDA Product Code PEX: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens.

Leading manufacturers include bioMerieux, Inc., Bruker Daltonics, Inc. and Bruker Daltonik GmbH.

5
Total
4
Cleared
231d
Avg days
2013
Since

FDA 510(k) Cleared System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Devices (Product Code PEX)

5 devices
1–5 of 5
Cleared Jul 26, 2017
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536
Bruker Daltonik GmbH
Microbiology · 222d
Cleared Jul 22, 2017
VITEK MS
K162950
bioMerieux, Inc.
Microbiology · 271d
Cleared Mar 27, 2015
MALDI Biotyper CA System
K142677
Bruker Daltonics, Inc.
Microbiology · 189d
Cleared Nov 21, 2013
MALDI BIOTYPER CA (MBT-CA) SYSTEM
K130831
Bruker Daltonics, Inc.
Microbiology · 240d
Not Cleared Aug 21, 2013
VITEK MS
DEN130013
bioMerieux, Inc.
Microbiology · 231d

About Product Code PEX - Regulatory Context