510(k) K061686
K061686 is an FDA 510(k) premarket notification submitted by Geneohm Sciences Canada, Inc. for the device "IDI-VANR ASSAY". The FDA issued a decision of Substantially Equivalent on August 30, 2006. The device falls under product code NIJ (System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species), a Class II device regulated under 21 CFR 866.1640. Geneohm Sciences Canada, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2006
- Date Received
- June 15, 2006
- 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