Progenika Biopharma S.A., A Grifols Company FDA Record
Progenika Biopharma S.A., A Grifols Company has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Progenika Biopharma S.A., A Grifols Company" is on file.
- Latest 510(k)
- Oct 27, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |
Progenika Biopharma S.A., A Grifols Company and the FDA: common questions
Has Progenika Biopharma S.A., A Grifols Company received an FDA warning letter?
No FDA warning letter addressed to the name "Progenika Biopharma S.A., A Grifols Company" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Progenika Biopharma S.A., A Grifols Company received an FDA Form 483?
FDA has not published a Form 483 for "Progenika Biopharma S.A., A Grifols Company" in its reading room. FDA publishes some Form 483s, not all of them.
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