510(k) K063127
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- October 13, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type
E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.