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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Genetic Variant Detection And Health Risk Assessment System
510(k) Number K221420
Device Name AlphaID™ At Home Genetic Health Risk Service
Applicant
Progenika Biopharma S.A., A Grifols Company
Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia
Derio,  ES 48160
Applicant Contact Diego Tejedor
Correspondent
Progenika Biopharma S.A., A Grifols Company
Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia
Derio,  ES 48160
Correspondent Contact Diego Tejedor
Regulation Number866.5950
Classification Product Code
PTA  
Date Received05/16/2022
Decision Date 10/27/2022
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
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