# 23AndMe, Inc.

- Location (FDA's records): Mountain View, CA
- FDA decisions: 8 (2015–2023): 5 510(k) clearances and 3 De Novo grants
- Names in FDA's records: 23AndMe, Inc. (7); 23AndMe (1)
- Product codes: QAZ (4), QDJ (3), PKB (1)
- Predicates its devices cite: 6 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN170046: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (2018), cited by 3
- K182784: MUTYH-Associated Polyposis (MAP) (2019), cited by 1
- K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2020), cited by 1
- DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2018), cited by 1

## Recent decisions
- K223597: 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (Aug 31, 2023)
- K221885: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (Oct 26, 2022)
- K211499: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (Jan 6, 2022)
- K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (Aug 17, 2020)
- K182784: MUTYH-Associated Polyposis (MAP) (Jan 18, 2019)
- DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (Oct 31, 2018)
- DEN170046: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (Mar 6, 2018)
- DEN140044: 23ANDME Personal Genome Service (Hereinafter Known as PGS) (Feb 19, 2015)

Source page: https://510kreport.com/company/23andme