FDA product code DNF: Liquid Chromatography, Ethosuximide
DNF is the FDA product code for liquid chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel. Devices under DNF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chromatography, 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 DNF devices
openFDA lists no recalls for product code DNF.
Frequently asked questions
What is FDA product code DNF?
DNF is the FDA product code for liquid chromatography, ethosuximide. It is a Class II device, regulated under 21 CFR 862.3380 and reviewed by the Clinical Toxicology panel.
What device class is DNF?
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 DNF
- Run a recall and safety report across every DNF manufacturer
- Watch product code DNF 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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