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