23AndMe, Inc.
Mountain View, CA, US
23AndMe, Inc. appears in FDA device records in Mountain View, CA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 9
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 9 510(k) clearances for 23AndMe, Inc. between 2015 and 2023. The busiest year on record is 2018, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | Substantially Equivalent | |
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Substantially Equivalent | |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | QAZ | Substantially Equivalent | |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Substantially Equivalent | |
| K182784 | MUTYH-Associated Polyposis (MAP) | QAZ | Substantially Equivalent | |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Unknown | |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | Unknown | |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | PTA | Unknown | |
| DEN140044 | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | PKB | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain