Clearance Summary
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 received FDA 510(k) clearance under submission number K052017, 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 2005-09-01.
- Submission: K052017
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1235
- Decision date: 2005-09-01
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.