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