FDA product code JNE: Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase
JNE is the FDA product code for glucose-6-phosphate (colorimetric), phosphohexose isomerase. It is a Class I device, regulated under 21 CFR 862.1570 and reviewed by the Clinical Chemistry panel. Devices under JNE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Glucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase |
| Device class | Class I |
| Regulation | 21 CFR 862.1570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNE devices
openFDA lists no recalls for product code JNE.
Frequently asked questions
What is FDA product code JNE?
JNE is the FDA product code for glucose-6-phosphate (colorimetric), phosphohexose isomerase. It is a Class I device, regulated under 21 CFR 862.1570 and reviewed by the Clinical Chemistry panel.
What device class is JNE?
Class I, regulation 21 CFR 862.1570. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNE
- Run a recall and safety report across every JNE manufacturer
- Watch product code JNE 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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