BEUDAMED
    Product Code: GIE FDA class 2 21 CFR 864.5400

    Fibrometer

    Hematology

    The Fibrometer (product code GIE) is an automated or semi-automated electromechanical instrument used in hematology laboratories to measure clot formation endpoints in coagulation assays, enabling determination of prothrombin time, APTT, fibrinogen levels, and other coagulation test results. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.5400 in the Hematology specialty (HE), this device carries no special regulatory flags.

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    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    0

    Basic Information

    Product Code
    GIE
    Device Class
    FDA class 2
    Regulation Number
    864.5400
    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
    K820533 B4182-1
    K820532 DISPO FIBRIN PIPET TIPS B4182-2

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.