LDO — Enzymatic Radiochemical Assay, Tobramycin Class II
FDA product code LDO covers "Enzymatic Radiochemical Assay, Tobramycin", a Class II medical device regulated under 21 CFR 862.3900. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDO
- Device Class
- Class II
- Regulation Number
- 862.3900
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No