• 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 genetic variant detection and health risk assessment system
De Novo Number DEN160026
Device Name 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
Requester
23andMe, Inc.
899 west evelyn avenue
mountain view,  CA  94041
Contact lisa charter
Regulation Number866.5950
Classification Product Code
PTA  
Date Received06/28/2016
Decision Date 04/06/2017
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Hematology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-