The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Avandx E. Faecalis/oe Pna Fish Culture Identification Kit.
| Device ID | K083074 |
| 510k Number | K083074 |
| Device Name: | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT |
| Classification | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis |
| Applicant | ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Contact | Paula E Bulger |
| Correspondent | Paula E Bulger ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Product Code | OAH |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-15 |
| Decision Date | 2009-07-24 |