DNL
8 FDA 510(k) clearances · Product code
27 daysmedian time to decision
65 days90th percentile
8clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- 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 |
|---|---|---|
| DIG RADIOIMMUNOASSAY TEST SYSTEM (K852343) | M Nobird, Inc. | 1985-07-09 |
| TIPSEP DIGOXIN RIA (K852291) | Nuclear Diagnostics, Inc. | 1985-06-25 |
| DIGOXIN (RIA) KIT (K811212) | Immuno Assay Corp. | 1981-05-21 |
| DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (K810966) | E. R. Squibb & Sons, Inc. | 1981-04-21 |
| DIGOXIN RADIOIMMUNOASSAY KIT (K802841) | American Diagnostic Corp. | 1980-12-18 |
| TEST SET, 125 I-DIGOXIN (K781834) | Wien Laboratories, Inc. | 1979-01-03 |
| RIANEN ASSAY SYSTEM, 125I KIT (K781495) | New England Nuclear | 1978-09-14 |
| IN VITRO DIGOXIN RIA TEST (K772110) | Clinical Assays, Inc. | 1977-11-22 |
Track DNL automatically
Every clearance here is in the API, with alerts when new ones post.