Total Ige-Fast Test
by Axonics Inc.
510(k) K823494
Total Ige-Fast Test is a medical device (FDA Class II; FDA product code DGC, Ige, Antigen, Antiserum, Control) made by Axonics Inc., cleared under FDA 510(k) K823494 on 14 Jan 1983, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823494 | Date14 Jan 1983 | StatusActive |
Official records
- FDA 510(k) database K823494
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DGC
- FDA applicant
- Axonics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
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