Data / Medical devices / United States / 23andMe Genomics LLC
23andMe Genomics LLC: FDA-registered device maker in Palo Alto, CA, United States, 10 510(k) clearances
23andMe Genomics LLC is registered with the FDA (registration 3007699459) in Palo Alto, CA, United States. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007699459
- Address
- 2555 Park Blvd, Palo Alto, CA, United States, 94306
- Owner or operator
- 23andMe Genomics LLC (10029404)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 20, 2015
- Registered through
- 2026
- Brand names listed
- 23andMe BRCA1/BRCA2 (Selected Variants) Report, 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related), 23andMe Personal Genome Service Pharmacogenetics Reports, 23andMe Pharmacogenetics Reports, Autosomal recessive carrier screening gene mutation detection system, Cancer predisposition risk assessment system, DNA specimen collection, saliva, Direct-to-consumer access pharmacogenetic assessment system and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Autosomal Recessive Carrier Screening Gene Mutation Detection System | PKB | 2 | Manufacturer | accessdata.fda.gov |
| Cancer Predisposition Risk Assessment System | QAZ | 2 | Manufacturer | accessdata.fda.gov |
| Direct-To-Consumer Access Pharmacogenetic Assessment System | QDJ | 2 | Manufacturer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Specification developer | accessdata.fda.gov |
| Genetic Variant Detection And Health Risk Assessment System | PTA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 31, 2023 | K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | Substantially Equivalent | 23AndMe, Inc. | accessdata.fda.gov |
| October 26, 2022 | K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Substantially Equivalent | 23AndMe, Inc. | accessdata.fda.gov |
| January 6, 2022 | K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | QAZ | Substantially Equivalent | 23AndMe, Inc. | accessdata.fda.gov |
| August 17, 2020 | K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Substantially Equivalent | 23AndMe, Inc. | accessdata.fda.gov |
| January 18, 2019 | K182784 | MUTYH-Associated Polyposis (MAP) | QAZ | Substantially Equivalent | 23AndMe, Inc. | accessdata.fda.gov |
| October 31, 2018 | DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | Unknown | 23AndMe, Inc. | accessdata.fda.gov |
| March 6, 2018 | DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | Unknown | 23AndMe, Inc. | accessdata.fda.gov |
| April 6, 2017 | DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | PTA | Unknown | 23AndMe, Inc. | accessdata.fda.gov |
| February 19, 2015 | K141410 | ORAGENE DX OGD-500.001 | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| February 19, 2015 | DEN140044 | 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS) | PKB | Unknown | 23AndMe | accessdata.fda.gov |
Compare with other makers
- All makers of Dna Specimen Collection, Saliva
- All makers of Genetic Variant Detection And Health Risk Assessment System
Updated August 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.