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

    VIROGEN RUBELLA SLIDE TEST

    K Number: K844435 · Decision May 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    68
    Review Days
    185

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    Basic Information

    Device Name
    VIROGEN RUBELLA SLIDE TEST
    K Number
    K844435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    November 16, 1984
    Decision Date
    May 20, 1985
    Product Code
    LQN
    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
    LQN Latex Agglutination Assay, Rubella

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