FDA product code DKR: Thin Layer Chromatography, Methadone
DKR is the FDA product code for thin layer chromatography, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. Devices under DKR reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer 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 DKR devices
openFDA lists no recalls for product code DKR.
Frequently asked questions
What is FDA product code DKR?
DKR is the FDA product code for thin layer 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 DKR?
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 DKR
- Run a recall and safety report across every DKR manufacturer
- Watch product code DKR 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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