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