510(k) K163536

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 26, 2017

Date Received

December 16, 2016

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

866.3361

Review Panel

MI

Submission Type

A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.