FDA product code JIE: Method, Ion-Exchange, Ammonia
JIE is the FDA product code for method, ion-exchange, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel. Devices under JIE reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Method, Ion-Exchange, Ammonia |
| Device class | Class I |
| Regulation | 21 CFR 862.1065 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JIE devices
openFDA lists no recalls for product code JIE.
Frequently asked questions
What is FDA product code JIE?
JIE is the FDA product code for method, ion-exchange, ammonia. It is a Class I device, regulated under 21 CFR 862.1065 and reviewed by the Clinical Chemistry panel.
What device class is JIE?
Class I, regulation 21 CFR 862.1065. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JIE
- Run a recall and safety report across every JIE manufacturer
- Watch product code JIE 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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