Clearance Summary
QUANTIMUNE FERRITIN IRMA received FDA 510(k) clearance under submission number K810799, 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 1981-04-03.
- Submission: K810799
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5340
- Decision date: 1981-04-03
Classification & Regulation
This clearance is catalogued under FDA product code JMG and 21 CFR 866.5340, within the Immunology review panel as a Class II device.