510(k) K223597
- Device
- 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- Applicant
- 23AndMe, Inc.
- 510(k) number
- K223597
- Product code
- QAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-31
- Date received
- 2022-12-02
- Regulation
- 866.6090
- Classification name
- Cancer Predisposition Risk Assessment System
- Medical specialty
- Medical Genetics
- Review panel
- Medical Genetics
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Marianna Frendo
- Address
- 349 Oyster Pt. Blvd. San Franciso CA US 94080 94080
FDA Registration Numbers#
- 3007699459
Source Documents#
Other 510(k) Records For Product Code QAZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 23AndMe, Inc. | 2022-01-06 |
| K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | 2019-01-18 |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | 2018-03-06 |