DOG
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
29 days90th percentile
5clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- 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 |
|---|---|---|
| DCA DIGOX-SYN RIA TEST (K810477) | Diagnostic Corp. of America | 1981-03-11 |
| IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (K803045) | American Dade | 1980-12-22 |
| DIGOXIN RIA (PEG) KIT (K781335) | Ortho Diagnostics, Inc. | 1978-08-31 |
| EMIT DIGOKIN ASSAY (K760709) | Syva Co. | 1976-10-21 |
| DATA-TOPE SYSTEM DIGOXIN RIA (K760416) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 |
Track DOG automatically
Every clearance here is in the API, with alerts when new ones post.