23ANDME Personal Genome Service (Hereinafter Known As Pgs)

No FDA recalls found in the data synced 10 Oct 2026.

De Novo Number

DEN140044 ↗

FDA Product Code

PKB

Device Class

Class II

Regulation

21 CFR Part 866.5940

Advisory Committee

Immunology

FDA Decision

DENG De Novo granted

• 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

  Class II

  FDA 510(k) K221885 Active Cleared 26 Oct 2022

• MUTYH-Associated Polyposis (MAP)

  Class II

  FDA 510(k) K182784 Active Cleared 18 Jan 2019

• 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

  Class II

  FDA De Novo DEN160026 Active Cleared 6 Apr 2017 FDA 510(k)

• 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

  Class II

  FDA De Novo DEN170046 Active Cleared 6 Mar 2018 FDA 510(k)

• 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

  Class II

  FDA 510(k) K223597 Active Cleared 31 Aug 2023

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

  Class II

  FDA 510(k) K211499 Active Cleared 6 Jan 2022

See all devices from 23AndMe, Inc. →