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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
Streck, Inc.
7002 s. 109th street
la vista,  NE  68128
Contact deborah kipp
Regulation Number862.1676
Classification Product Code
Date Received01/10/2020
Decision Date 08/07/2020
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct