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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 blood collection device for cell-free nucleic acid
De Novo Number DEN200001
Device Name Cell-Free DNA BCT
Requester
streck, inc.
7002 s 109th st.
la vista,  NE  68128
Contact deborah kipp
Regulation Number862.1676
Classification Product Code
QMA  
Date Received01/10/2020
Decision Date 08/07/2020
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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