FDA product code JHE: Radioassay, 17-Hydroxycorticosteroids
JHE is the FDA product code for radioassay, 17-hydroxycorticosteroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel. Devices under JHE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Radioassay, 17-Hydroxycorticosteroids |
| Device class | Class I |
| Regulation | 21 CFR 862.1385 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JHE devices
openFDA lists no recalls for product code JHE.
Frequently asked questions
What is FDA product code JHE?
JHE is the FDA product code for radioassay, 17-hydroxycorticosteroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel.
What device class is JHE?
Class I, regulation 21 CFR 862.1385. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JHE
- Run a recall and safety report across every JHE manufacturer
- Watch product code JHE 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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