BEUDAMED
    Product Code: KEY FDA class 1 21 CFR 864.3800

    Stainer, Tissue, Automated

    Pathology

    Automated Tissue Stainer is an instrument used in histopathology laboratories to automatically apply a sequence of reagents and stains to tissue sections mounted on microscope slides, standardizing the staining process and reducing manual handling 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 KEY, regulated under 21 CFR 864.3800, within the Pathology medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KEY
    Device Class
    FDA class 1
    Regulation Number
    864.3800
    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
    K771714 SLIDE STAINERS GLS 360 & 360-1

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.