FDA product code KEI: Condensers, Microscope
KEI is the FDA product code for condensers, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. Devices under KEI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Condensers, 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 KEI devices
openFDA lists no recalls for product code KEI.
Frequently asked questions
What is FDA product code KEI?
KEI is the FDA product code for condensers, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is KEI?
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 KEI
- Run a recall and safety report across every KEI manufacturer
- Watch product code KEI 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.
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