BEUDAMED
    Product Code: KEE FDA class 1 21 CFR 864.4010

    Osmium Tetroxide

    Pathology

    Osmium tetroxide is a heavy metal fixative reagent used in histopathology and electron microscopy to fix lipids and membranes in biological tissue specimens, providing excellent contrast for ultrastructural examination of cell organelles and membranous structures. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls. Product code KEE is regulated under 21 CFR 864.4010 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.

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

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    Basic Information

    Product Code
    KEE
    Device Class
    FDA class 1
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Review Panel
    PA
    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 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.