510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PEXClass II

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

21 CFR 866.3361 / Microbiology
FDA source (opens on fda.gov)

PEX is the FDA product code for System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates, a class II device type, regulated under 21 CFR 866.3361. FDA's definition for this code reads: "A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PEX
Device name
System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
FDA definition
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Regulation
21 CFR 866.3361
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
3

Clearances, product code PEX

By decision year
5 clearances under product code PEX with a decision year between 2013 and 2017, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PEX by decision year
YearClearances
20132
20151
20172

Applicants with the most clearances

Product code PEX
Applicants holding the most 510(k) clearances under product code PEX
ApplicantClearances
Bruker Daltonics2
bioMerieux, Inc.2
Bruker Daltonik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code