BEUDAMED
    Product Code: KKK FDA class 1 21 CFR 864.1850

    Sudan Iv

    Hematology

    Sudan IV is a synthetic fat-soluble azo dye used as a histological staining reagent in hematology and pathology, applied to detect and demonstrate neutral fats and lipids in tissue sections and cytological preparations under light microscopy. It is classified as FDA Class 1, indicating low risk subject only to general controls without requiring premarket submission. The product code is KKK and the applicable regulation is 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Research product code KKK in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KKK
    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

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K842916 SUDAN IV HERXHEIMER

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.