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