Clearance Summary
A1AT Genotyping Test received FDA 510(k) clearance under submission number K211115, sponsored by Progenika Biopharma S.A., A Grifols Company. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2021-05-13.
- Submission: K211115
- Applicant / Sponsor: Progenika Biopharma S.A., A Grifols Company
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5130
- Decision date: 2021-05-13
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.