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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 a medical device manufactured by 23AndMe, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval 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. It is manufactured by 23AndMe, Inc.. The 510(k) number is K182784.

When was MUTYH-Associated Polyposis (MAP) approved by the FDA?

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

What company makes MUTYH-Associated Polyposis (MAP)?

MUTYH-Associated Polyposis (MAP) is manufactured by 23AndMe, Inc..

What is the FDA product code for MUTYH-Associated Polyposis (MAP)?

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

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Related Devices (Code: QAZ)

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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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