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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name autosomal recessive carrier screening gene mutation detection system
De Novo Number DEN140044
Device Name 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
Requester
23andme
1390 shorebird way
mountain view,  CA  94043
Contact kathy hibbs
Regulation Number866.5940
Classification Product Code
PKB  
Date Received05/29/2014
Decision Date 02/19/2015
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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