FDA product code KJS: Ethyl Eosin
KJS is the FDA product code for ethyl eosin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KJS reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Ethyl Eosin |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for KJS devices
openFDA lists no recalls for product code KJS.
Frequently asked questions
What is FDA product code KJS?
KJS is the FDA product code for ethyl eosin. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KJS?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code KJS
- Run a recall and safety report across every KJS manufacturer
- Watch product code KJS 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.