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FDA 510(k) Application Details - DEN210011
Device Classification Name
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510(K) Number
DEN210011
Device Name
Invitae Common Hereditary Cancers Panel
Applicant
Invitae Corporation
1400 16th Street
San Francisco, CA 94103 US
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Contact
Elaine Cull
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QVU
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More FDA Info for this Product Code
Date Received
03/29/2021
Decision Date
09/29/2023
Decision
DENG -
Classification Advisory Committee
-
Review Advisory Committee
MG -
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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