Clearance Summary
QUANTIMUNE ESTRIOL RIA received FDA 510(k) clearance under submission number K820728, 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 1982-04-06.
- Submission: K820728
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1265
- Decision date: 1982-04-06
Classification & Regulation
This clearance is catalogued under FDA product code CGI and 21 CFR 862.1265, within the Clinical Chemistry review panel as a Class I device.