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

    MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

    K Number: K012138 · Decision Sep 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    11
    Applicant Total
    3
    Review Days
    447

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    Basic Information

    Device Name
    MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
    K Number
    K012138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chroma Vision Medical Systems, Inc.
    Date Received
    July 10, 2001
    Decision Date
    September 30, 2002
    Product Code
    MYA
    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
    MYA Immunohistochemistry Antibody Assay, Estrogen Receptor

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    Other Clearances by Chroma Vision Medical Systems, Inc.

    K Number Device Name
    K032113 ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
    K984188 AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)