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.
| Device ID | K221420 |
| 510k Number | K221420 |
| Device Name: | AlphaID™ At Home Genetic Health Risk Service |
| Classification | Genetic 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 |
| Contact | Diego Tejedor |
| Correspondent | Diego Tejedor Progenika Biopharma S.A., A Grifols Company Ibaizabal Bidea, Edificio 504, Parque Tecnológico De Bizkaia Derio, ES 48160 |
| Product Code | PTA |
| CFR Regulation Number | 866.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-10-27 |