DPB
10 FDA 510(k) clearances · Product code
21 daysmedian time to decision
125 days90th percentile
10clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal 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 |
|---|---|---|
| OPTIMATE DIGOXIN TEST (K853021) | Miles Laboratories, Inc. | 1985-08-07 |
| DIGOXIN KIT (K823014) | Pcl-Ria, Inc. | 1982-11-01 |
| 125I DIGOXIN RADIOIMMUNOASSAY KIT (K821811) | Cambridge Medical Technology | 1982-07-02 |
| DIGOXIN RADIOIMMUNOASSAY (K820274) | American Diagnostic Corp. | 1982-02-23 |
| DIGOXIN RADIOIMMUNOASSAY SYSTEM (K792153) | Radioimmunoassay, Inc. | 1979-11-13 |
| RIA, DIGNXIN-125-I (K790602) | Endocrine-Metabolic Center | 1979-07-30 |
| RIA TEST KIT, CENTRIA DIGOXIN (K790540) | Ventrex Laboratories, Inc. | 1979-04-23 |
| 125I DIGOXIN TEST SET (K772306) | Wien Laboratories, Inc. | 1977-12-22 |
| 125 I DIGOXIN RIA KIT (K771525) | Diagnostic Products Corp. | 1977-10-14 |
| DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY (K760883) | Nuclear Medical Laboratories, Inc. | 1976-11-19 |
Track DPB automatically
Every clearance here is in the API, with alerts when new ones post.