FDA product code KEG: Lamps, Microscope
KEG is the FDA product code for lamps, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. Devices under KEG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lamps, Microscope |
| Device class | Class I |
| Regulation | 21 CFR 864.3600 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KEG devices
openFDA lists no recalls for product code KEG.
Frequently asked questions
What is FDA product code KEG?
KEG is the FDA product code for lamps, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is KEG?
Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KEG
- Run a recall and safety report across every KEG manufacturer
- Watch product code KEG 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.