510(k) K063127
K063127 is an FDA 510(k) premarket notification submitted by Advandx, Inc. for the device "ENTEROCOCCUS FAECALIS PNA FISH". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code OAH (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis), a Class I device regulated under 21 CFR 866.3740. Advandx, Inc. has at least 10 other 510(k) clearances on record.
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.