BEUDAMED
    Product Code: KJX FDA class 1 21 CFR 864.1850

    Jenner Stain

    Hematology

    Jenner Stain is a Romanowsky-type histological dye used in hematology laboratories to stain blood smears and bone marrow specimens for the differential identification of blood cell types under microscopy. It is classified as FDA Class 1, indicating low risk subject to general controls only with no premarket submission required. The product code is KJX and it falls under 21 CFR 864.1850 within the Hematology specialty. This device is GMP exempt.

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

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    Basic Information

    Product Code
    KJX
    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
    K842928 JENNER BLOOD STAIN

    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.