BEUDAMED
    Product Code: IBM FDA class 1 21 CFR 864.3600

    Microscope, Phase Contrast

    Pathology

    A phase contrast microscope is a laboratory instrument that converts differences in optical path length through transparent specimens into variations in light intensity, enabling visualization of unstained living cells and transparent biological materials. 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 IBM, regulated under 21 CFR 864.3600, in the Pathology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IBM
    Device Class
    FDA class 1
    Regulation Number
    864.3600
    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
    K885091 HEMAVIEW DARKFIELD MICROSCOPE SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.