Documento fuente o registro público
FDA 510(k) K221640 — AlloMap Heart Molecular Expression Testing
FDA 510(k) index record K221640. Device: AlloMap Heart Molecular Expression Testing. Applicant as listed: Caredx, Inc.. Decision date: 2023-09-13.
Fuente
"device_name": "AlloMap Heart Molecular Expression Testing"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-28
professional use
FDA 510(k) public index record K221640.
Device name: AlloMap Heart Molecular Expression Testing. Applicant as listed: Caredx, Inc..
Decision date: 2023-09-13. Decision wording: Substantially Equivalent.
Product code: OJQ. Regulation: 21 CFR 862.1163. Medical specialty: Cardiovascular.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.