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