FDA product code JLE: Radioimmunoassay, Desoxycorticosterone
JLE is the FDA product code for radioimmunoassay, desoxycorticosterone. It is a Class I device, regulated under 21 CFR 862.1250 and reviewed by the Clinical Chemistry panel. Devices under JLE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Desoxycorticosterone |
| Device class | Class I |
| Regulation | 21 CFR 862.1250 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JLE devices
openFDA lists no recalls for product code JLE.
Frequently asked questions
What is FDA product code JLE?
JLE is the FDA product code for radioimmunoassay, desoxycorticosterone. It is a Class I device, regulated under 21 CFR 862.1250 and reviewed by the Clinical Chemistry panel.
What device class is JLE?
Class I, regulation 21 CFR 862.1250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JLE
- Run a recall and safety report across every JLE manufacturer
- Watch product code JLE 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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