DCE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fab, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5520
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ANTISERA, RHODAMINE CONJUGATED FRAGMENT (K781951) | Kallestad Laboratories, Inc. | 1979-02-16 |
| FLUORESCEIN CONJUGATED (K772128) | Kallestad Laboratories, Inc. | 1977-11-22 |
Track DCE automatically
Every clearance here is in the API, with alerts when new ones post.