FDA product code KKI: Rose Bengal
KKI is the FDA product code for rose bengal. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. Devices under KKI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Rose Bengal |
| 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 KKI devices
openFDA lists no recalls for product code KKI.
Frequently asked questions
What is FDA product code KKI?
KKI is the FDA product code for rose bengal. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is KKI?
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 KKI
- Run a recall and safety report across every KKI manufacturer
- Watch product code KKI 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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