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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 kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit
De Novo Number DEN240025
Device Name VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
Requester
ventana medical systems, inc.
1910 e innovation park dr.
tucso,  AZ  85755
Contact patricia wade
Regulation Number864.1861
Classification Product Code
SDP  
Date Received05/29/2024
Decision Date 12/05/2024
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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