FDA product code HZX: Silver Nitrate
HZX is the FDA product code for silver nitrate. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under HZX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Silver Nitrate |
| 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 HZX devices
openFDA lists no recalls for product code HZX.
Frequently asked questions
What is FDA product code HZX?
HZX is the FDA product code for silver nitrate. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is HZX?
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 HZX
- Run a recall and safety report across every HZX manufacturer
- Watch product code HZX 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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