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