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

    KRONUS OPTIQUANT THYROGLOBULIN KIT

    K Number: K991720 · Decision Aug 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    81

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    Basic Information

    Device Name
    KRONUS OPTIQUANT THYROGLOBULIN KIT
    K Number
    K991720
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unchanged
    Date Received
    May 20, 1999
    Decision Date
    August 9, 1999
    Product Code
    MSW
    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
    MSW System, Test, Thyroglobulin

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