Clearance Summary
CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR received FDA 510(k) clearance under submission number K041627, sponsored by Dako A/S. 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 2004-09-03.
- Submission: K041627
- Applicant / Sponsor: Dako A/S
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2004-09-03
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.