BEUDAMED
    Product Code: KKA FDA class 1 21 CFR 864.1850

    Methyl Orange

    Hematology

    Methyl Orange is a synthetic azo dye used as a histological staining reagent and pH indicator in hematology and laboratory diagnostics, aiding in the visualization and differentiation of tissue structures in microscopic preparations. It is classified as FDA Class 1, indicating low risk subject to general controls with no requirement for premarket clearance. The product code is KKA and it is regulated under 21 CFR 864.1850 within the Hematology specialty. This device is GMP exempt.

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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
    KKA
    Device Class
    FDA class 1
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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