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FDA 510(k)

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

K-Number: K211499 · 2022-01-06

Applicant23AndMe, Inc.
Decision Date2022-01-06
Product CodeQAZ
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K211499. The device is classified under product code QAZ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is 23AndMe, Inc.. The 510(k) number is K211499.

When did 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) receive FDA 510(k) clearance?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) received FDA 510(k) clearance on 2022-01-06, under 510(k) number K211499.

Who is the listed applicant for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

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 PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

The FDA product code for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is QAZ.

Related Clinical Trials

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.

NCT06654466Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary CancerACTIVE_NOT_RECRUITING

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 ReportsK19349223andMe Personal Genome Service (PGS) Pharmacogenetic ReportsK182784MUTYH-Associated Polyposis (MAP)

Related Devices (Code: QAZ)

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)23AndMe, Inc.K182784MUTYH-Associated Polyposis (MAP)23AndMe, 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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