Product code DIR
- Device name
- Free Radical Assay, Cocaine
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3250
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863888 | DU PONT PHENYTOIN ASSAY AND CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-11-05 |