FDA product code DJX: Radioimmunoassay, Ethosuximide
DJX is the FDA product code for radioimmunoassay, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel. Devices under DJX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Ethosuximide |
| Device class | Class II |
| Regulation | 21 CFR 862.3380 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DJX devices
openFDA lists no recalls for product code DJX.
Frequently asked questions
What is FDA product code DJX?
DJX is the FDA product code for radioimmunoassay, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel.
What device class is DJX?
Class II, regulation 21 CFR 862.3380. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DJX
- Run a recall and safety report across every DJX manufacturer
- Watch product code DJX 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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