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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 road
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
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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