Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SpainLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Grifols. FDA records under its name, each linked to the record. See the Grifols group view.
As of Nov 15, 2026, FDA's public records list Progenika Biopharma with 4 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 2022: AlphaID™ At Home Genetic Health Risk Service.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 27, 2022 | AlphaID™ At Home Genetic Health Risk ServiceK221420 · PTA | 510(k) clearances |
| May 13, 2021 | A1AT Genotyping TestK211115 · PZH | 510(k) clearances |
| Nov 5, 2019 | A1AT Genotyping TestK192858 · PZH | 510(k) clearances |
| Nov 11, 2017 | A1AT Genotyping TestK171868 · PZH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
