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FDA 510(k)

MUTYH-Associated Polyposis (MAP)

K-Number: K182784 · 2019-01-18

Applicant23AndMe, Inc.
Decision Date2019-01-18
Product CodeQAZ
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

MUTYH-Associated Polyposis (MAP) is the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K182784. 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 MUTYH-Associated Polyposis (MAP)?

MUTYH-Associated Polyposis (MAP) is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is 23AndMe, Inc.. The 510(k) number is K182784.

When did MUTYH-Associated Polyposis (MAP) receive FDA 510(k) clearance?

MUTYH-Associated Polyposis (MAP) received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182784.

Who is the listed applicant for MUTYH-Associated Polyposis (MAP)?

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 MUTYH-Associated Polyposis (MAP)?

The FDA product code for MUTYH-Associated Polyposis (MAP) is QAZ.

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)K19349223andMe Personal Genome Service (PGS) Pharmacogenetic Reports

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.K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc.

Official Source

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

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