Clearance Summary
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS received FDA 510(k) clearance under submission number K062128, sponsored by Dade Behring, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-08-21.
- Submission: K062128
- Applicant / Sponsor: Dade Behring, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2006-08-21
Classification & Regulation
This clearance is catalogued under FDA product code JHS and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.