Clearance Summary
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL received FDA 510(k) clearance under submission number K132031, sponsored by Axis-Shield Poc AS. 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 2014-03-21.
- Submission: K132031
- Applicant / Sponsor: Axis-Shield Poc AS
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1175
- Decision date: 2014-03-21
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.