FDA product code IHJ: Blender, Sputum
IHJ is the FDA product code for blender, sputum. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel. Devices under IHJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Blender, Sputum |
| 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 IHJ devices
openFDA lists no recalls for product code IHJ.
Frequently asked questions
What is FDA product code IHJ?
IHJ is the FDA product code for blender, sputum. It is a Class I device, regulated under 21 CFR 864.3010 and reviewed by the Pathology panel.
What device class is IHJ?
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 IHJ
- Run a recall and safety report across every IHJ manufacturer
- Watch product code IHJ 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.
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