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

    ACRIDINE ORANGE STAIN

    K Number: K803304 · Decision Feb 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    137
    Review Days
    44

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    Basic Information

    Device Name
    ACRIDINE ORANGE STAIN
    K Number
    K803304
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Remel Co.
    Date Received
    December 30, 1980
    Decision Date
    February 12, 1981
    Product Code
    IDC
    Advisory Committee
    Hematology
    Review Advisory Committee
    MI
    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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