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FDA 510(k)

AlloMap Heart Molecular Expression Testing

K-Number: K221640 · 2023-09-13

ApplicantCaredx, Inc.
Decision Date2023-09-13
Product CodeOJQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AlloMap Heart Molecular Expression Testing is a medical device manufactured by Caredx, Inc.. It received FDA 510(k) clearance on 2023-09-13 under approval number K221640. The device is classified under product code OJQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlloMap Heart Molecular Expression Testing?

AlloMap Heart Molecular Expression Testing is a medical device that received FDA 510(k) clearance on 2023-09-13. It is manufactured by Caredx, Inc.. The 510(k) number is K221640.

When was AlloMap Heart Molecular Expression Testing approved by the FDA?

AlloMap Heart Molecular Expression Testing received FDA 510(k) clearance on 2023-09-13, under approval number K221640.

What company makes AlloMap Heart Molecular Expression Testing?

AlloMap Heart Molecular Expression Testing is manufactured by Caredx, Inc..

What is the FDA product code for AlloMap Heart Molecular Expression Testing?

The FDA product code for AlloMap Heart Molecular Expression Testing is OJQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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