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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 adamts13 activity test system
De Novo Number DEN230024
Device Name Technozym ADAMTS13 Activity
Requester
technoclone herstellung von diagnostika und arzneimitteln gm
brunner strasse 67
vienna,  AT 1230
Contact nikolaus binder
Regulation Number864.7297
Classification Product Code
SAC  
Date Received04/06/2023
Decision Date 02/28/2024
Decision granted (DENG)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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