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

    CMV BIO-BEAD TITRATION KIT

    K Number: K801722 · Decision Sep 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    15
    Review Days
    55

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    Basic Information

    Device Name
    CMV BIO-BEAD TITRATION KIT
    K Number
    K801722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Litton Bionetics
    Date Received
    July 23, 1980
    Decision Date
    September 16, 1980
    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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