Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

K-Number: K193492 · 2020-08-17

Applicant23AndMe, Inc.
Decision Date2020-08-17
Product CodeQDJ
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is a medical device manufactured by 23AndMe, Inc.. It received FDA 510(k) clearance on 2020-08-17 under approval number K193492. The device is classified under product code QDJ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is a medical device that received FDA 510(k) clearance on 2020-08-17. It is manufactured by 23AndMe, Inc.. The 510(k) number is K193492.

When was 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports approved by the FDA?

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports received FDA 510(k) clearance on 2020-08-17, under approval number K193492.

What company makes 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is manufactured by 23AndMe, Inc..

What is the FDA product code for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

The FDA product code for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports is QDJ.

Related Clinical Trials

NCT07573098 Digital Tool for Improved Self-management of COPD RECRUITING

Other Devices by 23AndMe, Inc.

DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic Reports DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) K182784MUTYH-Associated Polyposis (MAP) K22188523andMe Personal Genome Service (PGS) Pharmacogenetic Reports K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

View all 8 devices →

Related Devices (Code: QDJ)

DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc. K22188523andMe Personal Genome Service (PGS) Pharmacogenetic Reports23AndMe, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑