BEUDAMED
    Product Code: JIZ FDA class 1 21 CFR 862.1410

    Atomic Absorption, Iron (Non-Heme)

    Clinical Chemistry

    This device is an atomic absorption spectroscopy reagent or system used to measure non-heme iron levels in clinical specimens, providing a high-specificity analytical method for diagnosing iron metabolism disorders including iron deficiency and iron overload conditions. It is classified as FDA Class 1 and is subject only to general controls, with no premarket submission required. The product code is JIZ, regulated under 21 CFR 862.1410, within the Clinical Chemistry medical specialty.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    JIZ
    Device Class
    FDA class 1
    Regulation Number
    862.1410
    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