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FDA 510(k) Application Details - K223597
Device Classification Name
More FDA Info for this Device
510(K) Number
K223597
Device Name
23andMe« Personal Genome Service« (PGS«) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Applicant
23andMe, Inc.
349 Oyster Point Blvd
South San Francisco, CA 94080 US
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Contact
Marianna Frendo
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Regulation Number
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Classification Product Code
QAZ
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More FDA Info for this Product Code
Date Received
12/02/2022
Decision Date
08/31/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MG -
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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