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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 jak2 gene mutation detection test
De Novo Number DEN160028
Device Name ipsogen JAK2 RGQ PCR Kit
Requester
qiagen inc
19300 germantown road
germantown,  MD  20874
Contact lindsey howard
Regulation Number866.6070
Classification Product Code
PSU  
Date Received07/01/2016
Decision Date 03/27/2017
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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