FDA product code IEH: Lamps, Slide Warming
IEH is the FDA product code for lamps, slide warming. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IEH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Lamps, Slide Warming |
| Device class | Class I |
| Regulation | 21 CFR 864.3010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for IEH devices
openFDA lists no recalls for product code IEH.
Frequently asked questions
What is FDA product code IEH?
IEH is the FDA product code for lamps, slide warming. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IEH?
Class I, regulation 21 CFR 864.3010. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IEH
- Run a recall and safety report across every IEH manufacturer
- Watch product code IEH 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.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times