BEUDAMED
    Product Code: KSN FDA class 2 21 CFR 864.9285

    Centrifuge, Cell-Washing, Automated For Immuno-Hematology

    Hematology

    This device is an automated cell-washing centrifuge for immunohematology, used in blood bank laboratories to wash red blood cells during antibody detection and identification procedures, removing unbound serum proteins to improve the sensitivity and specificity of serological tests. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSN, regulated under 21 CFR 864.9285 within the Hematology specialty. No special flags apply.

    View on FDA
    510(k)s
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    1
    Years Active
    —

    Research product code KSN in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    KSN
    Device Class
    FDA class 2
    Regulation Number
    864.9285
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.