FDA product code JNP: Infrared Spectroscopy Measurement, Urinary Calculi (Stone)
JNP is the FDA product code for infrared spectroscopy measurement, urinary calculi (stone). It is a Class I device, regulated under 21 CFR 862.1780 and reviewed by the Clinical Chemistry panel. Devices under JNP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Infrared Spectroscopy Measurement, Urinary Calculi (Stone) |
| Device class | Class I |
| Regulation | 21 CFR 862.1780 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JNP devices
openFDA lists no recalls for product code JNP.
Frequently asked questions
What is FDA product code JNP?
JNP is the FDA product code for infrared spectroscopy measurement, urinary calculi (stone). It is a Class I device, regulated under 21 CFR 862.1780 and reviewed by the Clinical Chemistry panel.
What device class is JNP?
Class I, regulation 21 CFR 862.1780. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JNP
- Run a recall and safety report across every JNP manufacturer
- Watch product code JNP 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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