23AndMe, Inc.
23AndMe, Inc. appears in FDA public data with 0 recalls, 9 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 31, 2023.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Varian | August 31, 2023 |
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | October 26, 2022 |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | January 6, 2022 |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | August 17, 2020 |
| K182784 | MUTYH-Associated Polyposis (MAP) | January 18, 2019 |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | October 31, 2018 |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | March 6, 2018 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | April 6, 2017 |
| DEN140044 | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | February 19, 2015 |