Clearance Summary
Cholesterol2 received FDA 510(k) clearance under submission number K203597, sponsored by Abbott Ireland Diagnostics Division. 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 2022-06-30.
- Submission: K203597
- Applicant / Sponsor: Abbott Ireland Diagnostics Division
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2022-06-30
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.