The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for S. Aureus Pna Fish.
| Device ID | K091827 |
| 510k Number | K091827 |
| Device Name: | S. AUREUS PNA FISH |
| Classification | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus |
| Applicant | ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Contact | Paula E Burger |
| Correspondent | Paula E Burger ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Product Code | NXX |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2009-08-18 |