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23AndMe, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
1
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected VarianAugust 31, 2023
K22188523andMe Personal Genome Service (PGS) Pharmacogenetic ReportsOctober 26, 2022
K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)January 6, 2022
K19349223andMe Personal Genome Service (PGS) Pharmacogenetic ReportsAugust 17, 2020
K182784MUTYH-Associated Polyposis (MAP)January 18, 2019
DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic ReportsOctober 31, 2018
DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)March 6, 2018
DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary ThrombophiliaApril 6, 2017
DEN14004423ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)February 19, 2015