De Novo DEN240067

Device: KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
Contact: steve chatters
De Novo number: DEN240067
Product code: SFS
Regulation: 864.1885
Classification name: revumenib eligibility detection system
Decision: granted (DENG)
Decision date: 2025-09-19
Date received: 2024-11-22
Classification advisory: Hematology
Review advisory: Molecular Genetics
Type: Direct

Current FDA Classification#

Product code: SFS
Device name: Revumenib Eligibility Detection System
Medical specialty: Hematology
Device class: 2
Regulation: 864.1885
Implant: N
Life sustain/support: N