Devices · BRUKER DALTONICS, INC

MALDI BIOTYPER CA (MBT-CA) SYSTEM

BRUKER DALTONICS, INC is listed for MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831). The FDA list gives November 21, 2013 as the date of the final decision. The lead panel is Microbiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code PEX as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K130831

Official FDA database record

Date of final decision

November 21, 2013

Company on the FDA list

BRUKER DALTONICS, INC

Lead panel

Microbiology

Primary product code

PEX

openFDA device name for the code

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

Device class

2

Regulation number

866.3361

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary