510(k) K142677
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2015
- Date Received
- September 19, 2014
- 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.