FDA product code JNZ: Fluorometric, Uroporphyrin
JNZ is the FDA product code for fluorometric, uroporphyrin. It is a Class I device, regulated under 21 CFR 862.1790 and reviewed by the Clinical Chemistry panel. Devices under JNZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric, Uroporphyrin |
| Device class | Class I |
| Regulation | 21 CFR 862.1790 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNZ devices
openFDA lists no recalls for product code JNZ.
Frequently asked questions
What is FDA product code JNZ?
JNZ is the FDA product code for fluorometric, uroporphyrin. It is a Class I device, regulated under 21 CFR 862.1790 and reviewed by the Clinical Chemistry panel.
What device class is JNZ?
Class I, regulation 21 CFR 862.1790. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNZ
- Run a recall and safety report across every JNZ manufacturer
- Watch product code JNZ 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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