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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 high throughput dna sequencing for hereditary cancer predisposition assessment test system.
De Novo Number DEN210011
Device Name Invitae Common Hereditary Cancers Panel
Requester
invitae corporation
1400 16th street
san francisco,  CA  94103
Contact elaine cull
Regulation Number866.6095
Classification Product Code
QVU  
Date Received03/29/2021
Decision Date 09/29/2023
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Molecular Genetics
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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