510(k) K092953
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2009
- Date Received
- September 24, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology