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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name revumenib eligibility detection system
De Novo Number DEN240067
Device Name KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
Requester
cytocell limited
oxford gene technology, 418 cambridge science park
milton rd.
cambridge,  GB cb4 0pz
Contact steve chatters
Regulation Number864.1885
Classification Product Code
SFS  
Date Received11/22/2024
Decision Date 09/19/2025
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Molecular Genetics
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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