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

    Virtuoso System for IHC PR (1E2) using iScan HT

    K Number: K142965 · Decision Jul 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    48
    Review Days
    275

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    Basic Information

    Device Name
    Virtuoso System for IHC PR (1E2) using iScan HT
    K Number
    K142965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ventana Medical Systems, Inc.
    Date Received
    October 14, 2014
    Decision Date
    July 16, 2015
    Product Code
    OEO
    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
    OEO Automated Digital Image Manual Interpretation Microscope

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