FDA product code JXQ: Monitor, U.V., Glc
JXQ is the FDA product code for monitor, u.v., glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. Devices under JXQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, U.V., Glc |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for JXQ devices
openFDA lists no recalls for product code JXQ.
Frequently asked questions
What is FDA product code JXQ?
JXQ is the FDA product code for monitor, u.v., glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is JXQ?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JXQ
- Run a recall and safety report across every JXQ manufacturer
- Watch product code JXQ 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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