AlphaID™ At Home Genetic Health Risk Service

Genetic Variant Detection And Health Risk Assessment System

Progenika Biopharma S.A., A Grifols Company

The following data is part of a premarket notification filed by Progenika Biopharma S.a., A Grifols Company with the FDA for Alphaid™ At Home Genetic Health Risk Service.

Pre-market Notification Details

Device IDK221420
510k NumberK221420
Device Name:AlphaID™ At Home Genetic Health Risk Service
ClassificationGenetic Variant Detection And Health Risk Assessment System
Applicant Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia Derio,  ES 48160
ContactDiego Tejedor
CorrespondentDiego Tejedor
Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia Derio,  ES 48160
Product CodePTA  
CFR Regulation Number866.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-10-27

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