FDA product code HZI: Acid, Osmic
HZI is the FDA product code for acid, osmic. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under HZI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Acid, Osmic |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HZI devices
openFDA lists no recalls for product code HZI.
Frequently asked questions
What is FDA product code HZI?
HZI is the FDA product code for acid, osmic. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is HZI?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HZI
- Run a recall and safety report across every HZI manufacturer
- Watch product code HZI 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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