Clearance Summary
QUANTIMUNE T-4 FIA received FDA 510(k) clearance under submission number K790576, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1979-07-30.
- Submission: K790576
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1700
- Decision date: 1979-07-30
Classification & Regulation
This clearance is catalogued under FDA product code CDX and 21 CFR 862.1700, within the Clinical Chemistry review panel as a Class II device.