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

    VIRATEST-DIA(TM) MEASLES (RUBEOLA)

    K Number: K910290 · Decision Mar 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    421

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    Basic Information

    Device Name
    VIRATEST-DIA(TM) MEASLES (RUBEOLA)
    K Number
    K910290
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3520
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Virus Reference Laboratory, Inc.
    Date Received
    January 22, 1991
    Decision Date
    March 18, 1992
    Product Code
    LJB
    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
    LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

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