DLE — Reagents, Test, Bromides Class II
FDA product code DLE covers "Reagents, Test, Bromides", a Class II medical device regulated under 21 CFR 862.3645. Submissions are reviewed by the Clinical Toxicology panel.
Classification Details
- Product Code
- DLE
- Device Class
- Class II
- Regulation Number
- 862.3645
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No