FDA product code DIK: Thin Layer Chromatography, Quinine
DIK is the FDA product code for thin layer chromatography, quinine. It is a Class I device, regulated under 21 CFR 862.3750 and reviewed by the Clinical Toxicology panel. Devices under DIK reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Quinine |
| Device class | Class I |
| Regulation | 21 CFR 862.3750 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DIK devices
openFDA lists no recalls for product code DIK.
Frequently asked questions
What is FDA product code DIK?
DIK is the FDA product code for thin layer chromatography, quinine. It is a Class I device, regulated under 21 CFR 862.3750 and reviewed by the Clinical Toxicology panel.
What device class is DIK?
Class I, regulation 21 CFR 862.3750. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DIK
- Run a recall and safety report across every DIK manufacturer
- Watch product code DIK 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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