DIR — Free Radical Assay, Cocaine Class II
FDA product code DIR covers "Free Radical Assay, Cocaine", a Class II medical device regulated under 21 CFR 862.3250. 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
- DIR
- Device Class
- Class II
- Regulation Number
- 862.3250
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K863888 | e.i. dupont de nemours and co | DU PONT PHENYTOIN ASSAY AND CALIBRATOR | November 5, 1986 |