510(k) K221640

Device

AlloMap Heart Molecular Expression Testing

Applicant

Caredx, Inc.

510(k) number

K221640

Product code

OJQ

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-13

Date received

2022-06-06

Regulation

862.1163

Classification name

Cardiac Allograft Gene Expression Profiling Test System

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No