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

    MODIFICATION TO SERAQUEST VCA IGM

    K Number: K033780 · Decision Jan 15, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    25
    Review Days
    42

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    Basic Information

    Device Name
    MODIFICATION TO SERAQUEST VCA IGM
    K Number
    K033780
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Intl., Inc.
    Date Received
    December 4, 2003
    Decision Date
    January 15, 2004
    Product Code
    LJN
    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
    LJN Antibody Igm, If, Epstein-Barr Virus

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