# Progenika Biopharma S.A., A Grifols Company

- Location (FDA's records): Derio, ES
- FDA decisions: 4 (2017–2022): 4 510(k) clearances
- Product codes: PZH (3), PTA (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sebia: 1 (https://510kreport.com/company/sebia)

## Its most-cited devices
- K192858: A1AT Genotyping Test (2019), cited by 1
- K171868: A1AT Genotyping Test (2017), cited by 1

## Recent decisions
- K221420: AlphaID™ At Home Genetic Health Risk Service (Oct 27, 2022)
- K211115: A1AT Genotyping Test (May 13, 2021)
- K192858: A1AT Genotyping Test (Nov 5, 2019)
- K171868: A1AT Genotyping Test (Nov 11, 2017)

Source page: https://510kreport.com/company/progenika-biopharma-sa-a-grifols