AlphaID At Home Genetic Health Risk Service— 510(k) K221420

Substantially Equivalent

Progenika Biopharma S.A., A Grifols Company

FDA 510(k) clearance K221420 for AlphaID At Home Genetic Health Risk Service, Substantially Equivalent on 2022-10-27. Applicant: Progenika Biopharma S.A., A Grifols Company.

Clearance details

Applicant: Progenika Biopharma S.A., A Grifols Company
Product code: Code PTA
Advisory panel: Immunology
Date received: 2022-05-16
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Derio, ES

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