FDA product code KEF: Paraformaldehyde
KEF is the FDA product code for paraformaldehyde. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Immunology panel. Devices under KEF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Paraformaldehyde |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | IM — Immunology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KEF devices
openFDA lists no recalls for product code KEF.
Frequently asked questions
What is FDA product code KEF?
KEF is the FDA product code for paraformaldehyde. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Immunology panel.
What device class is KEF?
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 KEF
- Run a recall and safety report across every KEF manufacturer
- Watch product code KEF 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.