Clearance Summary
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) received FDA 510(k) clearance under submission number K874875, sponsored by Boots-Celltech Diagnostics, Inc.. 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 1988-03-24.
- Submission: K874875
- Applicant / Sponsor: Boots-Celltech Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1695
- Decision date: 1988-03-24
Classification & Regulation
This clearance is catalogued under FDA product code CEC and 21 CFR 862.1695, within the Clinical Chemistry review panel as a Class II device.