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

    IVD TECHNOLOGIES ACHRAB TEST KIT

    K Number: K091468 · Decision Nov 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    186

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    Basic Information

    Device Name
    IVD TECHNOLOGIES ACHRAB TEST KIT
    K Number
    K091468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ivd Technologies
    Date Received
    May 18, 2009
    Decision Date
    November 20, 2009
    Product Code
    NST
    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
    NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

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