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

    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

    K Number: K090236 · Decision Apr 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    87
    Review Days
    84

    Basic Information

    Device Name
    DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
    K Number
    K090236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Received
    February 2, 2009
    Decision Date
    April 27, 2009
    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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