510(k) K191964
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 2021
- Date Received
- July 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- Device Class
- Class II
- Regulation Number
- 866.3378
- Review Panel
- MI
- Submission Type
An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).