23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related)

Cancer Predisposition Risk Assessment System

23andMe, Inc.

The following data is part of a premarket notification filed by 23andme, Inc. with the FDA for 23andme Pgs Genetic Risk Report For Hereditary Prostate Cancer (hoxb13-related).

Pre-market Notification Details

Device IDK211499
510k NumberK211499
Device Name:23andMe PGS Genetic Risk Report For Hereditary Prostate Cancer (HOXB13-Related)
ClassificationCancer Predisposition Risk Assessment System
Applicant 23andMe, Inc. 349 Oyster Point Blvd. South San Francisco,  CA  94080
ContactMarianna Frendo
CorrespondentMarianna Frendo
23andMe, Inc. 349 Oyster Point Blvd. South San Francisco,  CA  94080
Product CodeQAZ  
CFR Regulation Number866.6090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-14
Decision Date2022-01-06

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