BEUDAMED
    Product Code: KJY FDA class 1 21 CFR 864.1850

    Malachite Green

    Hematology

    Malachite Green is a triarylmethane dye used as a histological and microbiological staining reagent in hematology laboratories, applied to detect spores and stain tissue components for microscopic visualization. It is classified as FDA Class 1, indicating low risk subject only to general controls without requiring premarket clearance. The product code is KJY and it is regulated under 21 CFR 864.1850 in the Hematology specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KJY
    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
    K864033 RAPID ACID FAST STAIN

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.