BEUDAMED
    Product Code: GHC FDA class 1 21 CFR 864.6700

    Tube, Sedimentation Rate

    Hematology

    The Tube, Sedimentation Rate (product code GHC) is a calibrated glass or plastic tube used to perform the erythrocyte sedimentation rate (ESR) test, a nonspecific marker of systemic inflammation used in hematology and general laboratory medicine. 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 864.6700 in the Hematology specialty (HE), this device carries no special regulatory flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    GHC
    Device Class
    FDA class 1
    Regulation Number
    864.6700
    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
    K885114 SALMONELLA IFA*

    FEI Numbers

    This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.