FDA product code DKW: Test Reagents For Sulphanimide Derivatives
DKW is the FDA product code for test reagents for sulphanimide derivatives. It is a Class I device, regulated under 21 CFR 862.3850 and reviewed by the Clinical Toxicology panel. Devices under DKW reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Test Reagents For Sulphanimide Derivatives |
| Device class | Class I |
| Regulation | 21 CFR 862.3850 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DKW devices
openFDA lists no recalls for product code DKW.
Frequently asked questions
What is FDA product code DKW?
DKW is the FDA product code for test reagents for sulphanimide derivatives. It is a Class I device, regulated under 21 CFR 862.3850 and reviewed by the Clinical Toxicology panel.
What device class is DKW?
Class I, regulation 21 CFR 862.3850. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DKW
- Run a recall and safety report across every DKW manufacturer
- Watch product code DKW 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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