DES
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lambda, Fitc, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FITC GOAT ANTI-HUMAN LAMBA (K832267) | Gelco Diagnostics, Inc. | 1983-10-31 |
| FLUORESCEIN CONJUGATED IMMUNOGLOBULIN (K831903) | Dako Corp. | 1983-07-19 |
Track DES automatically
Every clearance here is in the API, with alerts when new ones post.