Clearance Summary
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 received FDA 510(k) clearance under submission number K890675, sponsored by Unipath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1989-03-06.
- Submission: K890675
- Applicant / Sponsor: Unipath , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 1989-03-06
Classification & Regulation
This clearance is catalogued under FDA product code CZW and 21 CFR 866.5240, within the Immunology review panel as a Class II device.