Clearance Summary
QUANTIMUNE CORTISOL RIA CORTISOL RADIO- received FDA 510(k) clearance under submission number K800045, 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 1980-01-23.
- Submission: K800045
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1205
- Decision date: 1980-01-23
Classification & Regulation
This clearance is catalogued under FDA product code CGR and 21 CFR 862.1205, within the Clinical Chemistry review panel as a Class II device.