AlloMap Heart Molecular Expression Testing— 510(k) K221640

Name: FDA 510(k) clearance K221640
Creator: U.S. Food and Drug Administration
Published: 2023-09-13

Substantially Equivalent

Caredx, Inc.

FDA 510(k) clearance K221640 for AlloMap Heart Molecular Expression Testing, Substantially Equivalent on 2023-09-13. Applicant: Caredx, Inc.. Device class: 2.

Clearance details

Applicant: Caredx, Inc.
Product code: Code OJQ
Device class: Class 2
Regulation: 21 CFR 862.1163
Advisory panel: Cardiovascular
Date received: 2022-06-06
Decision date: 2023-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OJQ

view all

DEN080007 — ALLOMAP MOLECULAR EXPRESSION TESTING2008-08-26

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