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