The following data is part of a premarket notification filed by Axonics, Inc. with the FDA for Total Ige-fast Test.
| Device ID | K823494 |
| 510k Number | K823494 |
| Device Name: | TOTAL IGE-FAST TEST |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | AXONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-23 |
| Decision Date | 1983-01-14 |