FDA product code CDE: Chromatographic Separation/Zimmerman, 17-Ketosteroids
CDE is the FDA product code for chromatographic separation/zimmerman, 17-ketosteroids. It is a Class I device, regulated under 21 CFR 862.1430 and reviewed by the Clinical Chemistry panel. Devices under CDE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromatographic Separation/Zimmerman, 17-Ketosteroids |
| Device class | Class I |
| Regulation | 21 CFR 862.1430 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CDE devices
openFDA lists no recalls for product code CDE.
Frequently asked questions
What is FDA product code CDE?
CDE is the FDA product code for chromatographic separation/zimmerman, 17-ketosteroids. It is a Class I device, regulated under 21 CFR 862.1430 and reviewed by the Clinical Chemistry panel.
What device class is CDE?
Class I, regulation 21 CFR 862.1430. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CDE
- Run a recall and safety report across every CDE manufacturer
- Watch product code CDE 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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