FDA product code IAZ: Heparin
IAZ is the FDA product code for heparin. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Hematology panel. Devices under IAZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Heparin |
| Device class | Class I |
| Regulation | 21 CFR 864.4400 |
| Review panel | HE — Hematology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Recalls for IAZ devices
openFDA lists no recalls for product code IAZ.
Frequently asked questions
What is FDA product code IAZ?
IAZ is the FDA product code for heparin. It is a Class I device, regulated under 21 CFR 864.4400 and reviewed by the Hematology panel.
What device class is IAZ?
Class I, regulation 21 CFR 864.4400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code IAZ
- Run a recall and safety report across every IAZ manufacturer
- Watch product code IAZ 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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