BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ANEUVYSION MULITICOLOR DNA PROBE KIT

    K Number: K010288 · Decision Apr 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    72

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    Basic Information

    Device Name
    ANEUVYSION MULITICOLOR DNA PROBE KIT
    K Number
    K010288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4700
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vysis
    Date Received
    January 31, 2001
    Decision Date
    April 13, 2001
    Product Code
    OYU
    Advisory Committee
    Immunology
    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
    OYU Dna-Probe Kit, Human Chromosome

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    K953591 CEP 8 SPECTRUMORANGE DNA PROBE KIT