BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)

    K Number: K893466 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    36
    Review Days
    72

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    Basic Information

    Device Name
    CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
    K Number
    K893466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Concepts, Inc.
    Date Received
    May 3, 1989
    Decision Date
    July 14, 1989
    Product Code
    LKQ
    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
    LKQ Antibody Igm,If, Cytomegalovirus Virus

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    ACCURUN 146 CMV IGM POSITIVE CONTROL

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    BARTELS CYTOMEGALOVIRUS IGM EIA

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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. →