DKA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antiserum, Digoxin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (K934003) | Baxter Diagnostics, Inc. | 1994-11-22 |
| CBR-DIGOXIN ANTISERUM (K780498) | Clinical Bioresearch | 1978-04-05 |
| RABBIT ANTIBODY TO DIGOXIN (K780316) | Pcl-Ria, Inc. | 1978-03-17 |
Track DKA automatically
Every clearance here is in the API, with alerts when new ones post.