De Novo Classifications
FDA submissions for De Novo Classifications in the Hematology (HE) review panel, including product codes, regulations, and recent device decisions.
Section range: § 864.1885
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| SFS | Revumenib Eligibility Detection System | 864.1885 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | Sep 19, 2025 |
