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

    Elecsys AFP

    K Number: K220176 · Decision Sep 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    183
    Review Days
    237

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    Basic Information

    Device Name
    Elecsys AFP
    K Number
    K220176
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    January 21, 2022
    Decision Date
    September 15, 2022
    Product Code
    LOJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer

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