BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACRIDINE ORANGE FLUORESCENT STAIN

    K Number: K853187 · Decision Aug 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    14

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    Basic Information

    Device Name
    ACRIDINE ORANGE FLUORESCENT STAIN
    K Number
    K853187
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Technology, Inc.
    Date Received
    July 30, 1985
    Decision Date
    August 13, 1985
    Product Code
    IDC
    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
    IDC Acridine Orange

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