Clearance Summary
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY received FDA 510(k) clearance under submission number K053061, sponsored by Dade Behring, Inc.. 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 2006-02-06.
- Submission: K053061
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1235
- Decision date: 2006-02-06
Classification & Regulation
This clearance is catalogued under FDA product code MKW and 21 CFR 862.1235, within the Clinical Chemistry review panel as a Class II device.