The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Allergenetics Fluoro-fast Reader.
| Device ID | K831870 |
| 510k Number | K831870 |
| Device Name: | ALLERGENETICS FLUORO-FAST READER |
| Classification | Fluorometer |
| Applicant | AXONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-10 |
| Decision Date | 1983-08-12 |