Clearance Summary
COTUBE(TM) TSH IRMA received FDA 510(k) clearance under submission number K890802, 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 1989-03-28.
- Submission: K890802
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1690
- Decision date: 1989-03-28
Classification & Regulation
This clearance is catalogued under FDA product code JLW and 21 CFR 862.1690, within the Clinical Chemistry review panel as a Class II device.