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 the device name listed in this FDA 510(k) record. The listed applicant is Caredx, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) 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. The listed applicant is Caredx, Inc.. The 510(k) number is K221640.
When did AlloMap Heart Molecular Expression Testing receive FDA 510(k) clearance?
AlloMap Heart Molecular Expression Testing received FDA 510(k) clearance on 2023-09-13, under 510(k) number K221640.
Who is the listed applicant for AlloMap Heart Molecular Expression Testing?
The FDA 510(k) record lists Caredx, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AlloMap Heart Molecular Expression Testing?
The FDA product code for AlloMap Heart Molecular Expression Testing is OJQ.
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.