BEUDAMED
    Product Code: IDM FDA class 1 21 CFR 864.3010

    Microtome, Ultra

    Pathology

    An ultramicrotome is a precision tissue-sectioning instrument used in electron microscopy preparation to cut extremely thin sections (typically 50-100 nanometers) from resin-embedded biological specimens for examination under a transmission electron microscope. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IDM, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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

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    Basic Information

    Product Code
    IDM
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    PA
    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
    K812158 LKB-BROMMA 2188 ULTROTOME NOVA

    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.