BEUDAMED
    Product Code: KSY FDA class 1 21 CFR 864.9185

    Boxes, View, Blood Grouping

    Hematology

    This device consists of blood grouping view boxes, illuminated panels or light boxes used in blood bank laboratories to provide consistent backlighting when visually reading and interpreting agglutination reactions in blood grouping tests. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KSY, regulated under 21 CFR 864.9185 within the Hematology specialty. No special flags apply.

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

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    Basic Information

    Product Code
    KSY
    Device Class
    FDA class 1
    Regulation Number
    864.9185
    Medical Specialty
    Hematology
    Review Panel
    HE
    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
    K792306 RH VIEWBOX

    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.