A1AT Genotyping Test— 510(k) K171868
Substantially EquivalentProgenika Biopharma S.A., A Grifols Company
FDA 510(k) clearance K171868 for A1AT Genotyping Test, Substantially Equivalent on 2017-11-11. Applicant: Progenika Biopharma S.A., A Grifols Company.
Clearance details
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Product code
- Code PZH
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Derio, ES
Data sourced from openFDA. This site is unofficial and independent of the FDA.