DND — Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. Class II
FDA product code DND covers "Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.", a Class II medical device regulated under 21 CFR 862.3300. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DND
- Device Class
- Class II
- Regulation Number
- 862.3300
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K760077 | smithkline diagnostics | TEST, RIA, SERUM DIGOXIN | July 16, 1976 |