Clearance Summary
ELEGANCE FERRITIN ELISA received FDA 510(k) clearance under submission number K904822, sponsored by Bioclone Australia Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1990-11-29.
- Submission: K904822
- Applicant / Sponsor: Bioclone Australia Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1990-11-29
Classification & Regulation
This clearance is catalogued under FDA product code DBF and 21 CFR 866.5340, within the Immunology review panel as a Class II device.