AlphaID At Home Genetic Health Risk Service— 510(k) K221420
Substantially EquivalentProgenika 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. Device class: 2.
Clearance details
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Product code
- Code PTA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5950
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Derio, ES
Recent devices under product code PTA
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