DEN240067
- 510(k) number
- DEN240067
- Device name
- KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
- Applicant
- Cytocell Limited GB
- Product code
- SFS — Revumenib Eligibility Detection System
- Decision date
- 2025-09-19
- Date received
- 2024-11-22
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Hematology
Official FDA record: DEN240067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.