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 Street |
toronto,
CA
m6s1 v2
|
|
Applicant Contact |
gloria lee |
Correspondent |
Helix OpCo, LLC |
96 Colbeck Street |
toronto,
CA
m6s1 v2
|
|
Correspondent Contact |
gloria lee |
Regulation Number | 866.5950
|
Classification Product Code |
|
Date Received | 08/02/2019 |
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
|
|
|