DPB — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. Class II
FDA product code DPB covers "Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- DPB
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- 510(k)
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K853021 | Miles Laboratories | OPTIMATE DIGOXIN TEST | Aug 7, 1985 |
| K823014 | Pcl-Ria | DIGOXIN KIT | Nov 1, 1982 |
| K821811 | Cambridge Medical Technology | 125I DIGOXIN RADIOIMMUNOASSAY KIT | Jul 2, 1982 |
| K820274 | American Diagnostic | DIGOXIN RADIOIMMUNOASSAY | Feb 23, 1982 |
| K792153 | Radioimmunoassay | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Nov 13, 1979 |
| K790602 | Endocrine-Metabolic Center | RIA, DIGNXIN-125-I | Jul 30, 1979 |
| K790540 | Ventrex Laboratories | RIA TEST KIT, CENTRIA DIGOXIN | Apr 23, 1979 |
| K772306 | Wien Laboratories | 125I DIGOXIN TEST SET | Dec 22, 1977 |
| K771525 | Diagnostic Products | 125 I DIGOXIN RIA KIT | Oct 14, 1977 |
| K760883 | Nuclear Medical Laboratories | DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY | Nov 19, 1976 |