FDA 510(k) Applications for Medical Device Product Code "OJQ"
(Cardiac Allograft Gene Expression Profiling Test System)

FDA 510(k) Number Applicant Device Name Decision Date
K221640 CareDx, Inc. AlloMap Heart Molecular Expression Testing 09/13/2023
DEN080007 XDX ALLOMAP MOLECULAR EXPRESSION TESTING 08/26/2008


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