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

    VIDAS CMV IGM ASSAY

    K Number: K933549 · Decision Aug 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    49
    Review Days
    376

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    Basic Information

    Device Name
    VIDAS CMV IGM ASSAY
    K Number
    K933549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux Vitek, Inc.
    Date Received
    July 22, 1993
    Decision Date
    August 2, 1994
    Product Code
    LKQ
    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
    LKQ Antibody Igm,If, Cytomegalovirus Virus

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    K955647 VIDAS ESTRADIOL II (E2II) ASSAY
    K943812 VIDAS LYME SCREEN II
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