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