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

510(k) Premarket Notification
  • 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 direct-to-consumer access pharmacogenetic assessment system
510(k) Number K193492
Device Name 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
Applicant
23andMe, Inc.
223 N Mathilda Ave
Sunnyvale,  CA  94086
Applicant Contact Lisa Charter
Correspondent
23andMe, Inc.
223 N Mathilda Ave
Sunnyvale,  CA  94086
Correspondent Contact Marianna Frendo
Regulation Number862.3364
Classification Product Code
QDJ  
Date Received12/17/2019
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Molecular Genetics
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-