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

    EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)

    K Number: K895708 · Decision Dec 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    36
    Review Days
    77

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    Basic Information

    Device Name
    EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
    K Number
    K895708
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Concepts, Inc.
    Date Received
    September 25, 1989
    Decision Date
    December 11, 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 Immuno Concepts, Inc.

    K Number Device Name
    K013432 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
    K013285 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
    K013283 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
    K992041 RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
    K983924 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
    K972145 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
    K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMS
    K974463 IMMUNO CONCEPTS ANCA TEST SYSTEM
    K963275 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
    K955605 RELISA JO-1 ANTIBODY TEST SYSTEM
    Search all 36 clearances from Immuno Concepts, Inc. →