23andMe Personal Genome Service (PGS) Pharmacogenetic Reports— 510(k) K221885
Substantially Equivalent23AndMe, Inc.
FDA 510(k) clearance K221885 for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, Substantially Equivalent on 2022-10-26. Applicant: 23AndMe, Inc.. Device class: 2.
Clearance details
- Applicant
- 23AndMe, Inc.
- Product code
- Code QDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3364
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Franciso, CA, US
Recent devices under product code QDJ
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- K182784 — MUTYH-Associated Polyposis (MAP)
- DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
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Data sourced from openFDA. This site is unofficial and independent of the FDA.