23AndMe, Inc. FDA Record
23AndMe, Inc. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "23AndMe, Inc." is on file.
- Latest 510(k)
- Aug 31, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected… | 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 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | Apr 6, 2017 |
| DEN140044 | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | Feb 19, 2015 |
23AndMe, Inc. and the FDA: common questions
Has 23AndMe, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "23AndMe, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has 23AndMe, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "23AndMe, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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