FDA product code DOM: Thin Layer Chromatography, Benzoylecgnonine
DOM is the FDA product code for thin layer chromatography, benzoylecgnonine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. Devices under DOM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Benzoylecgnonine |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for DOM devices
openFDA lists no recalls for product code DOM.
Frequently asked questions
What is FDA product code DOM?
DOM is the FDA product code for thin layer chromatography, benzoylecgnonine. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DOM?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code DOM
- Run a recall and safety report across every DOM manufacturer
- Watch product code DOM 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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