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