Clearance Summary
Cholestech LDX System received FDA 510(k) clearance under submission number K223179, sponsored by Alere San Diego, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2023-09-20.
- Submission: K223179
- Applicant / Sponsor: Alere San Diego, Inc.
- Clearance pathway: Dual Track
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2023-09-20
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.