BEUDAMED
    Product Code: GHO FDA class 1 21 CFR 864.6160

    Hemocytometer

    Hematology

    The Hemocytometer (product code GHO) is a precision-calibrated counting chamber used with a microscope to manually enumerate blood cells, bacteria, or other particles in a known volume of fluid, serving as a fundamental tool in hematology and clinical laboratory practice. 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 864.6160 in the Hematology specialty (HE), this device carries no special regulatory flags.

    View on FDA
    510(k)s
    2
    FEI Numbers
    30
    Registration Numbers
    30
    Unique Applicants
    2
    Years Active
    10

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    Basic Information

    Product Code
    GHO
    Device Class
    FDA class 1
    Regulation Number
    864.6160
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K871671 URINOSCOPY FUNNEL
    K770980 EMATOLOGY DILUENT RESERVOIR CLOSURE

    FEI Numbers

    This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.