FDA product code JKQ: Gold Chloride (Colorimetric), Bromide
JKQ is the FDA product code for gold chloride (colorimetric), bromide. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. Devices under JKQ reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gold Chloride (Colorimetric), Bromide |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for JKQ devices
openFDA lists no recalls for product code JKQ.
Frequently asked questions
What is FDA product code JKQ?
JKQ is the FDA product code for gold chloride (colorimetric), bromide. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is JKQ?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code JKQ
- Run a recall and safety report across every JKQ manufacturer
- Watch product code JKQ 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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