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

    ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM

    K Number: K042092 · Decision Apr 12, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    135
    Review Days
    252

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    Basic Information

    Device Name
    ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
    K Number
    K042092
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeus Scientific, Inc.
    Date Received
    August 3, 2004
    Decision Date
    April 12, 2005
    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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