FDA product code JNX: Membrane Osmometry, Plasma Oncometry
JNX is the FDA product code for membrane osmometry, plasma oncometry. It is a Class I device, regulated under 21 CFR 862.1530 and reviewed by the Clinical Chemistry panel. Devices under JNX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Membrane Osmometry, Plasma Oncometry |
| Device class | Class I |
| Regulation | 21 CFR 862.1530 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNX devices
openFDA lists no recalls for product code JNX.
Frequently asked questions
What is FDA product code JNX?
JNX is the FDA product code for membrane osmometry, plasma oncometry. It is a Class I device, regulated under 21 CFR 862.1530 and reviewed by the Clinical Chemistry panel.
What device class is JNX?
Class I, regulation 21 CFR 862.1530. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNX
- Run a recall and safety report across every JNX manufacturer
- Watch product code JNX 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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