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