BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    IKAROS

    K Number: K940240 · Decision Feb 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    401

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    Basic Information

    Device Name
    IKAROS
    K Number
    K940240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5260
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metasystems GmbH
    Date Received
    January 19, 1994
    Decision Date
    February 24, 1995
    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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