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

    EBNA-1 IGM ELISA TEST SYSTEM

    K Number: K980598 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    73

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    Basic Information

    Device Name
    EBNA-1 IGM ELISA TEST SYSTEM
    K Number
    K980598
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clark Laboratories, Inc.
    Date Received
    February 17, 1998
    Decision Date
    May 1, 1998
    Product Code
    LLM
    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
    LLM Test, Antigen, Nuclear, Epstein-Barr Virus

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    Other Clearances by Clark Laboratories, Inc.

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    K925826 ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA
    K923537 ENCORE DS-DNA
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