Clearance Summary
A1AT Genotyping Test received FDA 510(k) clearance under submission number K171868, sponsored by Progenika Biopharma S.A., A Grifols Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-11-11.
- Submission: K171868
- Applicant / Sponsor: Progenika Biopharma S.A., A Grifols Company
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5130
- Decision date: 2017-11-11
Classification & Regulation
This clearance is catalogued under FDA product code PZH and 21 CFR 866.5130, within the Immunology review panel as a Class II device.