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

    SERAQUEST ANTI-THYROID PEROXIDASE (TPO)

    K Number: K023593 · Decision Feb 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    25
    Review Days
    104

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    Basic Information

    Device Name
    SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
    K Number
    K023593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Intl., Inc.
    Date Received
    October 25, 2002
    Decision Date
    February 6, 2003
    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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