23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)— 510(k) K211499
Substantially Equivalent23AndMe, Inc.
FDA 510(k) clearance K211499 for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related), Substantially Equivalent on 2022-01-06. Applicant: 23AndMe, Inc.. Device class: 2.
Clearance details
- Applicant
- 23AndMe, Inc.
- Product code
- Code QAZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6090
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Franciso, CA, US
Recent devices under product code QAZ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.