Clearance Summary
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH received FDA 510(k) clearance under submission number K063647, sponsored by Thermo Electron OY. 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 2007-03-12.
- Submission: K063647
- Applicant / Sponsor: Thermo Electron OY
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2007-03-12
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.