Clearance Summary
COTUBE LH IRMA ASSAY received FDA 510(k) clearance under submission number K884498, 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 1988-12-22.
- Submission: K884498
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1988-12-22
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.