BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    J & S IRON SATURATING REAGENT

    K Number: K811942 · Decision Sep 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    J & S IRON SATURATING REAGENT
    K Number
    K811942
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Thyroid Diagnostics, Inc.
    Date Received
    July 7, 1981
    Decision Date
    September 8, 1981
    Product Code
    JQF
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JQF Bathophenanthroline, Iron Binding Capacity

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    Other Clearances by Thyroid Diagnostics, Inc.

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