FDA product code JHA: Acid, Uric, Uricase (Gasometric)
JHA is the FDA product code for acid, uric, uricase (gasometric). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. Devices under JHA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Uric, Uricase (Gasometric) |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JHA devices
openFDA lists no recalls for product code JHA.
Frequently asked questions
What is FDA product code JHA?
JHA is the FDA product code for acid, uric, uricase (gasometric). It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is JHA?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JHA
- Run a recall and safety report across every JHA manufacturer
- Watch product code JHA 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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