DIR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Free Radical Assay, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| DU PONT PHENYTOIN ASSAY AND CALIBRATOR (K863888) | E.I. Dupont DE Nemours & Co., Inc. | 1986-11-05 | + Add |
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