Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Device Classification Name cancer predisposition risk assessment system
De Novo Number DEN170046
Device Name 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Requester
23andme, inc.
899 w.evelyn ave
mountain view,  CA  94041
Contact lisa charter
Regulation Number866.6090
Classification Product Code
QAZ  
Date Received09/05/2017
Decision Date 03/06/2018
Decision granted (DENG)
Classification Advisory Committee Molecular Genetics
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-