BEUDAMED
    Product Code: JKY FDA class 1 21 CFR 862.1190

    Oxalydihydrazide (Spectroscopic), Copper

    Clinical Chemistry

    This device is a spectroscopic clinical chemistry reagent system using oxalydihydrazide to measure copper concentrations in patient specimens, used in diagnosing copper metabolism disorders such as Wilson disease, Menkes disease, and copper toxicity. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket notification. The product code is JKY, regulated under 21 CFR 862.1190, within the Clinical Chemistry medical specialty.

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    Basic Information

    Product Code
    JKY
    Device Class
    FDA class 1
    Regulation Number
    862.1190
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting