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

    ALPCO MILENIA ANTI-TPO ELISA

    K Number: K011201 · Decision May 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    27
    Review Days
    35

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    Basic Information

    Device Name
    ALPCO MILENIA ANTI-TPO ELISA
    K Number
    K011201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    April 19, 2001
    Decision Date
    May 24, 2001
    Product Code
    JZO
    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
    JZO System, Test, Thyroid Autoantibody

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