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. Device class: 2.
Clearance details
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Product code
- Code PZH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Derio, ES
Recent devices under product code PZH
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