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