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

    MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT

    K Number: K864565 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    25
    Review Days
    92

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    Basic Information

    Device Name
    MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
    K Number
    K864565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Serono Diagnostics, Inc.
    Date Received
    November 19, 1986
    Decision Date
    February 19, 1987
    Product Code
    GQH
    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
    GQH Antigen, Cf (Including Cf Control), Cytomegalovirus

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    K873186 LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
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    K872862 PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
    Search all 25 clearances from Serono Diagnostics, Inc. →