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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 Number
866.6095
Classification Product Code
QVU
Date Received
03/29/2021
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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