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

    CMV-EA MAB TEST

    K Number: K912592 · Decision Dec 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    16
    Applicant Total
    57
    Review Days
    177

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    Basic Information

    Device Name
    CMV-EA MAB TEST
    K Number
    K912592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gull Laboratories, Inc.
    Date Received
    June 10, 1991
    Decision Date
    December 4, 1991
    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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