BEUDAMED
    Product Code: GGY FDA class 1 21 CFR 864.6160

    Pipette, Diluting

    Hematology

    The Pipette, Diluting (product code GGY) is a calibrated manual pipette used in hematology laboratories to prepare precise dilutions of blood samples prior to cell counting or other quantitative analyses. 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
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GGY
    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

    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.