DJI — Antiserum, Gentamicin Class II
FDA product code DJI covers "Antiserum, Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. 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
- DJI
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K812050 | kallestad laboratories | KALLESTAD ANTISERA TO GENTAMICIN | August 3, 1981 |