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