Clearance Summary
QUANTIMUNE(R) FERRITIN IRMA received FDA 510(k) clearance under submission number K863487, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1986-10-01.
- Submission: K863487
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1986-10-01
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.