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