FDA product code CES: Chromogenesis, Phenylketones (Urinary, Non-Quant.)
CES is the FDA product code for chromogenesis, phenylketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1560 and reviewed by the Clinical Chemistry panel. Devices under CES reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Chromogenesis, Phenylketones (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1560 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CES devices
openFDA lists no recalls for product code CES.
Frequently asked questions
What is FDA product code CES?
CES is the FDA product code for chromogenesis, phenylketones (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1560 and reviewed by the Clinical Chemistry panel.
What device class is CES?
Class I, regulation 21 CFR 862.1560. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CES
- Run a recall and safety report across every CES manufacturer
- Watch product code CES 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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