BEUDAMED
    Product Code: KIM FDA class 1 21 CFR 864.3400

    Device For Sealing Microsections

    Pathology

    Device for Sealing Microsections is a laboratory device used in pathology to apply a sealant or coverslip adhesive over tissue microsections mounted on slides, permanently preserving the specimen and preventing drying, contamination, or deterioration over time. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIM, regulated under 21 CFR 864.3400, within the Pathology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KIM
    Device Class
    FDA class 1
    Regulation Number
    864.3400
    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
    K780261 COVERSLIPPER

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.