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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
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