Clearance Summary
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M received FDA 510(k) clearance under submission number K193525, sponsored by HORIBA ABX SAS. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2020-06-26.
- Submission: K193525
- Applicant / Sponsor: HORIBA ABX SAS
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2020-06-26
Classification & Regulation
This clearance is catalogued under FDA product code CZP and 21 CFR 866.5510, within the Immunology review panel as a Class II device.