The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for C. Albicans Pna Fish.
| Device ID | K062461 |
| 510k Number | K062461 |
| Device Name: | C. ALBICANS PNA FISH |
| Classification | Kit, Identification, Yeast |
| Applicant | ADVANDX, INC. 690 CANTON STREET, SUITE 302 Westwood, MA 02090 |
| Contact | Amy Aulwes |
| Correspondent | Amy Aulwes ADVANDX, INC. 690 CANTON STREET, SUITE 302 Westwood, MA 02090 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-23 |
| Decision Date | 2006-10-25 |