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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cancer predisposition risk assessment system
510(k) Number K182784
Device Name MUTYH-Associated Polyposis (MAP)
Applicant
23andMe, Inc.
899 W. Evelyn Ave., CA
mountain view,  CA  94041
Applicant Contact sarah rys
Correspondent
23andMe, Inc.
899 W. Evelyn Ave., CA
mountain view,  CA  94041
Correspondent Contact sarah rys
Regulation Number866.6090
Classification Product Code
QAZ  
Date Received10/01/2018
Decision Date 01/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Molecular Genetics
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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