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