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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 prognostic test for assessment of liver related disease progression
De Novo Number DEN190056
Device Name ADVIA Centaur Enhanced Liver Fibrosis (ELF)
Siemens Healthcare Diagnostics Inc.
511 benedict ave
tarrytown,  NY  10591
Contact matthew gee
Regulation Number862.1622
Classification Product Code
Date Received12/26/2019
Decision Date 08/20/2021
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct