FDA product code HYH: Gold Chloride
HYH is the FDA product code for gold chloride. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under HYH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Gold Chloride |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HYH devices
openFDA lists no recalls for product code HYH.
Frequently asked questions
What is FDA product code HYH?
HYH is the FDA product code for gold chloride. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HYH?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HYH
- Run a recall and safety report across every HYH manufacturer
- Watch product code HYH 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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