Clearance Summary
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER received FDA 510(k) clearance under submission number K080384, sponsored by The Binding Site, Ltd.. 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 2008-06-06.
- Submission: K080384
- Applicant / Sponsor: The Binding Site, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2008-06-06
Classification & Regulation
This clearance is catalogued under FDA product code NDY and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.