FDA 510(k) Application Details - K221420

Device Classification Name	More FDA Info for this Device
510(K) Number	K221420
Device Name	AlphaIDÖ At Home Genetic Health Risk Service
Applicant	Progenika Biopharma S.A., a Grifols company Ibaizabal bidea, Edificio 504, Parque Tecnol≤gico de Bizkaia Derio 48160 ES Other 510(k) Applications for this Company
Contact	Diego Tejedor 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	05/16/2022
Decision Date	10/27/2022
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