K221640
- 510(k) number
- K221640
- Device name
- AlloMap Heart Molecular Expression Testing
- Applicant
- Caredx, Inc. CA · US
- Product code
- OJQ — Cardiac Allograft Gene Expression Profiling Test Sys
- Decision date
- 2023-09-13
- Date received
- 2022-06-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K221640.pdf
Official FDA record: K221640
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.