Clearance Summary
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer received FDA 510(k) clearance under submission number K161837, sponsored by Beckman Coulter, 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 2016-12-16.
- Submission: K161837
- Applicant / Sponsor: Beckman Coulter, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1665
- Decision date: 2016-12-16
Classification & Regulation
This clearance is catalogued under FDA product code JGS and 21 CFR 862.1665, within the Clinical Chemistry review panel as a Class II device.