DOGClass II
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
21 CFR 862.3320 / Clinical Toxicology
DOG is the FDA product code for Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol, a class II device type, regulated under 21 CFR 862.3320. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DOG
- Device name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- 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
- 5
- Ingested recalls
- 0
Clearances, product code DOG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1978 | 1 |
| 1980 | 1 |
| 1981 | 1 |
Applicants with the most clearances
Product code DOG| Applicant | Clearances |
|---|---|
| American Dade | 1 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 |
| Diagnostic Corp. of America | 1 |
| Ortho Diagnostics, Inc. | 1 |
| Syva Co. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code DOG.
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