FDA product code IEZ: Celloidin
IEZ is the FDA product code for celloidin. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. Devices under IEZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Celloidin |
| 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 IEZ devices
openFDA lists no recalls for product code IEZ.
Frequently asked questions
What is FDA product code IEZ?
IEZ is the FDA product code for celloidin. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IEZ?
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 IEZ
- Run a recall and safety report across every IEZ manufacturer
- Watch product code IEZ 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.