Clearance Summary
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES received FDA 510(k) clearance under submission number K232404, sponsored by Medicon Hellas S.A. 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 2024-08-09.
- Submission: K232404
- Applicant / Sponsor: Medicon Hellas S.A
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2024-08-09
Classification & Regulation
This clearance is catalogued under FDA product code CHH and 21 CFR 862.1175, within the Clinical Chemistry review panel as a Class I device.