BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CYTOSCAN

    K Number: K864955 · Decision Mar 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    CYTOSCAN
    K Number
    K864955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Image Recognition Systems , Ltd.
    Date Received
    December 18, 1986
    Decision Date
    March 16, 1987
    Product Code
    LNJ
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNJ Analyzer, Chromosome, Automated

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