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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cardiac allograft gene expression profiling test system
510(k) Number K221640
Device Name AlloMap Heart Molecular Expression Testing
CareDx, Inc.
3260 Bayshore Boulevard
Brisbane,  CA  94005
Applicant Contact Camilla Lu
CareDx, Inc.
3260 Bayshore Boulevard
Brisbane,  CA  94005
Correspondent Contact Camilla Lu
Regulation Number862.1163
Classification Product Code
Date Received06/06/2022
Decision Date 09/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No