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