PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates Class II
Classification Details
- Product Code
- PEX
- Device Class
- Class II
- Regulation Number
- 866.3361
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163536 | bruker daltonik | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | July 26, 2017 |
| K162950 | biomerieux | VITEK MS | July 22, 2017 |
| K142677 | bruker daltonics | MALDI Biotyper CA System | March 27, 2015 |
| K130831 | bruker daltonics | MALDI BIOTYPER CA (MBT-CA) SYSTEM | November 21, 2013 |
| DEN130013 | biomerieux | VITEK MS | August 21, 2013 |