Product code
HYR: Leuco-patent blue
FDA product code · Class I · Pathology
Key facts
| Product code | HYR |
|---|---|
| Device | Leuco-patent blue |
| Device class | Class I |
| Regulation number | 864.1850 |
| Review panel | Pathology |
| Medical specialty | Hematology |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database