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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 anti-factor xa activity test system, apixaban
De Novo Number DEN190032
Device Name HemosIL Liquid Anti-Xa
Requester
instrumentation laboratory co.
180 hartwell road
bedford,  MA  01730
Contact carol marble
Regulation Number864.7295
Classification Product Code
QLU  
Date Received06/25/2019
Decision Date 09/17/2020
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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