Chrysalis Intelligence · Sponsors · 23AndMe, Inc.

23AndMe, Inc.

Sunnyvale, CA, US · 4 510(k) clearances

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Total clearances
4
2020-08-17 → 2023-08-31
Last 12 months
0
Product codes
2
Most recent
2023-08-31
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QAZ Cancer Predisposition Risk Assessment System Class II Medical Genetics 2 2023-08-31
QDJ Direct-To-Consumer Access Pharmacogenetic Assessment System Class II Medical Genetics 2 2022-10-26
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2023-08-31 K223597 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) QAZ Class II Medical Genetics
2022-10-26 K221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports QDJ Class II Medical Genetics
2022-01-06 K211499 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) QAZ Class II Medical Genetics
2020-08-17 K193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports QDJ Class II Medical Genetics
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence