Clearance Summary
AlloMap Heart Molecular Expression Testing received FDA 510(k) clearance under submission number K221640, sponsored by Caredx, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-09-13.
- Submission: K221640
- Applicant / Sponsor: Caredx, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 862.1163
- Decision date: 2023-09-13
Classification & Regulation
This clearance is catalogued under FDA product code OJQ and 21 CFR 862.1163, within the Cardiovascular review panel as a Class II device.