FDA product code JHD: Fluorometric Method, 17-Hydroxycorticosteroids
JHD is the FDA product code for fluorometric method, 17-hydroxycorticosteroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel. Devices under JHD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric Method, 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 JHD devices
openFDA lists no recalls for product code JHD.
Frequently asked questions
What is FDA product code JHD?
JHD is the FDA product code for fluorometric method, 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 JHD?
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 JHD
- Run a recall and safety report across every JHD manufacturer
- Watch product code JHD 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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