BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AlloMap Heart Molecular Expression Testing

    K Number: K221640 · Decision Sep 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    464

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    Basic Information

    Device Name
    AlloMap Heart Molecular Expression Testing
    K Number
    K221640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1163
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caredx, Inc.
    Date Received
    June 6, 2022
    Decision Date
    September 13, 2023
    Product Code
    OJQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OJQ Cardiac Allograft Gene Expression Profiling Test System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OJQ), ordered by most recent decision date.

    ALLOMAP MOLECULAR EXPRESSION TESTING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all