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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 circulating tumor cell (ctc) enrichment device
De Novo Number DEN200062
Device Name Parsortix PC1 Device
Requester
angle europe , ltd.
10 nugent rd.
guildford,  GB gu2 7af
Contact andrew newland
Regulation Number866.6110
Classification Product Code
QSA  
Date Received09/28/2020
Decision Date 05/24/2022
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Molecular Genetics
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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