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

    EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

    K Number: K894626 · Decision Oct 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    88

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    Basic Information

    Device Name
    EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
    K Number
    K894626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bion Ent., Ltd.
    Date Received
    July 20, 1989
    Decision Date
    October 16, 1989
    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 Bion Ent., Ltd.

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    K894624 MUMPS VIRUS
    K894623 RESPIRATORY SYNCYTIAL VIRUS
    K891785 BION EBV-G (VCA) TEST SYSTEM
    K894625 CHLAMYDIA (LGV-1)
    K893240 BION EBV-M (VCA) TEST SYSTEM
    K890616 BION DIRECT IDENTIFICATION CONTROL SLIDE
    K881261 BION HSV1-G OR HSV2-G TEST SYSTEM
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