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

    CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

    K Number: K921616 · Decision Aug 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    16
    Applicant Total
    58
    Review Days
    127

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    Basic Information

    Device Name
    CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
    K Number
    K921616
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Incstar Corp.
    Date Received
    April 6, 1992
    Decision Date
    August 11, 1992
    Product Code
    LIN
    Advisory Committee
    Microbiology
    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
    LIN Antisera, Conjugated Fluorescent, Cytomegalovirus

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