FDA product code DKT: Free Radical Assay, Opiates
DKT is the FDA product code for free radical assay, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. Devices under DKT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Free Radical Assay, Opiates |
| Device class | Class II |
| Regulation | 21 CFR 862.3650 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DKT devices
openFDA lists no recalls for product code DKT.
Frequently asked questions
What is FDA product code DKT?
DKT is the FDA product code for free radical assay, opiates. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is DKT?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DKT
- Run a recall and safety report across every DKT manufacturer
- Watch product code DKT 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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