BEUDAMED
    Product Code: KKJ FDA class 1 21 CFR 864.1850

    Sudan Iii

    Hematology

    Sudan III is a synthetic oil-soluble azo dye used as a histological staining reagent in hematology and pathology laboratories, primarily applied to demonstrate lipids, fats, and lipoproteins in tissue sections and blood smears under microscopy. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance requirement. The product code is KKJ and it falls under 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KKJ
    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
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K810875 FECAL STAINING KIT

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.