The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for S. Aureus Pna Fish.
| Device ID | K060099 |
| 510k Number | K060099 |
| Device Name: | S. AUREUS PNA FISH |
| Classification | Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus |
| Applicant | ADVANDX, INC. 690 CANTON STREET, SUITE 302 Westwood, MA 02090 |
| Contact | Amy Auwles |
| Correspondent | Amy Auwles ADVANDX, INC. 690 CANTON STREET, SUITE 302 Westwood, MA 02090 |
| Product Code | NXX |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-13 |
| Decision Date | 2006-05-08 |