BEUDAMED
    Product Code: JCG FDA class 1 21 CFR 864.8200

    Fluid, Diluting, Manual Cell

    Hematology

    A manual cell diluting fluid is a reagent used in hematology laboratories to dilute blood specimens before manual cell counting procedures, providing a suitable medium that preserves cell morphology and allows accurate enumeration of blood cells. It is classified as FDA Class 1, the lowest risk designation, requiring only general controls with no premarket notification needed. The product code is JCG, regulated under 21 CFR 864.8200, within the Hematology medical specialty. No special flags apply to this device.

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

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    Basic Information

    Product Code
    JCG
    Device Class
    FDA class 1
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Review Panel
    HE
    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
    K892658 SDI PREPAX COUNTAPETTE KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.