FDA product code DNT: Liquid Chromatography, Methadone
DNT is the FDA product code for liquid chromatography, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. Devices under DNT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chromatography, Methadone |
| Device class | Class II |
| Regulation | 21 CFR 862.3620 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DNT devices
openFDA lists no recalls for product code DNT.
Frequently asked questions
What is FDA product code DNT?
DNT is the FDA product code for liquid chromatography, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel.
What device class is DNT?
Class II, regulation 21 CFR 862.3620. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DNT
- Run a recall and safety report across every DNT manufacturer
- Watch product code DNT 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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