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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 von willebrand factor assay
De Novo Number DEN200067
Device Name INNOVANCE VWF Ac
Requester
siemens healthcare diagnostics products gmbh
emil-von-behring strasse 76
marburg,  DE 35041
Contact petra dissmann
Regulation Number864.7293
Classification Product Code
QTY  
Date Received10/28/2020
Decision Date 09/29/2022
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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