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

    AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET

    K Number: K853081 · Decision Aug 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET
    K Number
    K853081
    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 23, 1985
    Decision Date
    August 13, 1985
    Product Code
    KJK
    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
    KJK Auramine O

    Similar 510(k) Clearances

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    AURAMINE O MYCROBACTERIAL STAIN SET

    FDA 510(k)
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