FDA product code KFL: Microtome, Sliding
KFL is the FDA product code for microtome, sliding. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under KFL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microtome, Sliding |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KFL devices
openFDA lists no recalls for product code KFL.
Frequently asked questions
What is FDA product code KFL?
KFL is the FDA product code for microtome, sliding. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is KFL?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KFL
- Run a recall and safety report across every KFL manufacturer
- Watch product code KFL 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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