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23AndMe, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories3
Latest Approval2023-08-31
TypeNumberDevice NameCodeDate
510(k) K223597 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) QAZ 2023-08-31 View
510(k) K221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports QDJ 2022-10-26 View
510(k) K211499 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) QAZ 2022-01-06 View
510(k) K193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports QDJ 2020-08-17 View
510(k) K182784 MUTYH-Associated Polyposis (MAP) QAZ 2019-01-18 View
510(k) DEN180028 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports QDJ 2018-10-31 View
510(k) DEN170046 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) QAZ 2018-03-06 View
510(k) DEN160026 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia PTA 2017-04-06 View
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