BEUDAMED
    Product Code: KIY FDA class 1 21 CFR 864.2240

    Chamber, Slide Culture

    Hematology

    Slide Culture Chamber is a laboratory device that creates a controlled microenvironment on a standard microscope slide, allowing cells to be grown directly on the slide surface so that they can be examined by microscopy without removing them from the culture vessel, used in cell biology and diagnostic laboratory applications. 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 KIY, regulated under 21 CFR 864.2240, within the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    KIY
    Device Class
    FDA class 1
    Regulation Number
    864.2240
    Medical Specialty
    Hematology
    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
    K781516 TEST SYSTEM TISSUE CELL CULTURE SLIDE

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.