The following data is part of a premarket notification filed by Advandx, Inc. with the FDA for Ek/p. Aeruginosa Pna Fish.
| Device ID | K081433 |
| 510k Number | K081433 |
| Device Name: | EK/P. AERUGINOSA PNA FISH |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Contact | Henrik Stender |
| Correspondent | Henrik Stender ADVANDX, INC. 10A ROESSLER ROAD Woburn, MA 01801 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-21 |
| Decision Date | 2009-03-26 |