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