BEUDAMED
    Product Code: GHK FDA class 1 21 CFR 864.5350

    Centrifuge, Microsedimentation

    Hematology

    The Centrifuge, Microsedimentation (product code GHK) is a laboratory instrument used to centrifuge microhematocrit tubes for the rapid determination of packed red blood cell volume (hematocrit), a standard measurement in hematology workups. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.5350 in the Hematology specialty (HE), this device carries no special regulatory flags.

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    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    GHK
    Device Class
    FDA class 1
    Regulation Number
    864.5350
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.