FDA product code DJL: Free Radical Assay, Amphetamine
DJL is the FDA product code for free radical assay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. Devices under DJL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Free Radical Assay, Amphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DJL devices
openFDA lists no recalls for product code DJL.
Frequently asked questions
What is FDA product code DJL?
DJL is the FDA product code for free radical assay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DJL?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DJL
- Run a recall and safety report across every DJL manufacturer
- Watch product code DJL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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