DeviceClearance

AlloMap Heart Molecular Expression Testing— 510(k) K221640

Substantially Equivalent

Caredx, Inc.

FDA 510(k) clearance K221640 for AlloMap Heart Molecular Expression Testing, Substantially Equivalent on 2023-09-13. Applicant: Caredx, Inc..

Clearance details

Applicant
Caredx, Inc.
Product code
Code OJQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brisbane, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.