FDA 510(k) Application Details - K192073

Device Classification Name	More FDA Info for this Device
510(K) Number	K192073
Device Name	Helix Genetic Health Risk App for late-onset AlzheimerÆs disease
Applicant	Helix OpCo, LLC 96 Colbeck Street Toronto M6S1 V2 CA Other 510(k) Applications for this Company
Contact	Gloria Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2019
Decision Date	12/23/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review