FDA product code JNQ: Qualitative Chemical Reactions, Urinary Calculi (Stone)
JNQ is the FDA product code for qualitative chemical reactions, urinary calculi (stone). It is a Class I device, regulated under 21 CFR 862.1780 and reviewed by the Clinical Chemistry panel. Devices under JNQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Qualitative Chemical Reactions, 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 JNQ devices
openFDA lists no recalls for product code JNQ.
Frequently asked questions
What is FDA product code JNQ?
JNQ is the FDA product code for qualitative chemical reactions, 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 JNQ?
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 JNQ
- Run a recall and safety report across every JNQ manufacturer
- Watch product code JNQ 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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