BEUDAMED
    Product Code: GGJ FDA class 1 21 CFR 864.8200

    Fluid, Diluting, White-Cell

    Hematology

    The Fluid, Diluting, White-Cell (product code GGJ) is a reagent used to dilute blood samples and lyse red blood cells prior to manual white blood cell counting, enabling accurate enumeration of leukocytes in hematology laboratories. This device is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.8200 in the Hematology specialty (HE), this device carries no special regulatory flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GGJ
    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
    K926422 VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.