Progenika Biopharma S.A., A Grifols Company
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K221420 | AlphaID At Home Genetic Health Risk Service | October 27, 2022 |
| K211115 | A1AT Genotyping Test | May 13, 2021 |
| K192858 | A1AT Genotyping Test | November 5, 2019 |
| K171868 | A1AT Genotyping Test | November 11, 2017 |