DOG — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol Class II
FDA product code DOG covers "Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DOG
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K810477 | diagnostic corp. of america | DCA DIGOX-SYN RIA TEST | March 11, 1981 |
| K803045 | american dade | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | December 22, 1980 |
| K781335 | ortho diagnostics | DIGOXIN RIA (PEG) KIT | August 31, 1978 |
| K760709 | syva | EMIT DIGOKIN ASSAY | October 21, 1976 |
| K760416 | dade, baxter travenol diagnostics | DATA-TOPE SYSTEM DIGOXIN RIA | August 23, 1976 |