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

    FASTPACK FREE T4 IMMUNOASSAY

    K Number: K030329 · Decision Jul 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    91
    Applicant Total
    15
    Review Days
    153

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    Basic Information

    Device Name
    FASTPACK FREE T4 IMMUNOASSAY
    K Number
    K030329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1695
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qualigen, Inc.
    Date Received
    January 31, 2003
    Decision Date
    July 3, 2003
    Product Code
    CEC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CEC Radioimmunoassay, Free Thyroxine

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