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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 the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2020-08-17 under 510(k) 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. The listed applicant is 23AndMe, Inc.. The 510(k) number is K193492.

When did 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports receive FDA 510(k) clearance?

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

Who is the listed applicant for 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports?

The FDA 510(k) record lists 23AndMe, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing 23AndMe, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)K22188523andMe Personal Genome Service (PGS) Pharmacogenetic ReportsK21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)K182784MUTYH-Associated Polyposis (MAP)

Related Devices (Code: QDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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