DPJ — Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep. Class II
FDA product code DPJ covers "Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DPJ
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No