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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 fish based detection of chromosomal abnormalities from patients with hematologic malignancies
De Novo Number DEN170070
Device Name MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe K
Cytocell Ltd
3-4 technopark, newmarket road
cambridge,  GB cb5 8pb
Contact xavier baker
Regulation Number864.1880
Classification Product Code
Date Received09/29/2017
Decision Date 12/21/2018
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Molecular Genetics
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct