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