FDA product code JNC: Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
JNC is the FDA product code for column or paper chromatography plus ninhydrin, phenylalanine. It is a Class II device, regulated under 21 CFR 862.1555 and reviewed by the Clinical Chemistry panel. Devices under JNC reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine |
| Device class | Class II |
| Regulation | 21 CFR 862.1555 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JNC devices
openFDA lists no recalls for product code JNC.
Frequently asked questions
What is FDA product code JNC?
JNC is the FDA product code for column or paper chromatography plus ninhydrin, phenylalanine. It is a Class II device, regulated under 21 CFR 862.1555 and reviewed by the Clinical Chemistry panel.
What device class is JNC?
Class II, regulation 21 CFR 862.1555. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JNC
- Run a recall and safety report across every JNC manufacturer
- Watch product code JNC 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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