Clearance Summary
AFINION ACR AND ACR CONTROL received FDA 510(k) clearance under submission number K072409, 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 2008-02-12.
- Submission: K072409
- Applicant / Sponsor: Axis-Shield Poc AS
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1225
- Decision date: 2008-02-12
Classification & Regulation
This clearance is catalogued under FDA product code JFY and 21 CFR 862.1225, within the Clinical Chemistry review panel as a Class II device.