FDA product code CHA: Radioimmunoassay, Corticosterone
CHA is the FDA product code for radioimmunoassay, corticosterone. It is a Class I device, regulated under 21 CFR 862.1200 and reviewed by the Clinical Chemistry panel. Devices under CHA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Corticosterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1200 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for CHA devices
openFDA lists no recalls for product code CHA.
Frequently asked questions
What is FDA product code CHA?
CHA is the FDA product code for radioimmunoassay, corticosterone. It is a Class I device, regulated under 21 CFR 862.1200 and reviewed by the Clinical Chemistry panel.
What device class is CHA?
Class I, regulation 21 CFR 862.1200. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code CHA
- Run a recall and safety report across every CHA manufacturer
- Watch product code CHA 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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