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 Genetic Variant Detection And Health Risk Assessment System
510(k) Number K192073
Device Name Helix Genetic Health Risk App for late-onset Alzheimer’s disease
Applicant
Helix Opco, LLC
96 Colbeck St.
Toronto,  CA M6S1 V2
Applicant Contact Gloria Lee
Correspondent
Helix Opco, LLC
96 Colbeck St.
Toronto,  CA M6S1 V2
Correspondent Contact Gloria Lee
Regulation Number866.5950
Classification Product Code
PTA  
Date Received08/02/2019
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-