DOAClass II
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
21 CFR 862.3320 / Clinical Toxicology
DOA is the FDA product code for Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep., a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- DOA
- Device name
- Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
- Regulation
- 21 CFR 862.3320
- Device class
- Class II
- Review panel
- Clinical Toxicology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code DOA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 1 |
Applicants with the most clearances
Product code DOA| Applicant | Clearances |
|---|---|
| Linde Medical Sensors AG | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
