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

    EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)

    K Number: K880886 · Decision Aug 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    36
    Review Days
    181

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    Basic Information

    Device Name
    EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
    K Number
    K880886
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Concepts, Inc.
    Date Received
    March 2, 1988
    Decision Date
    August 30, 1988
    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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    Other Clearances by Immuno Concepts, Inc.

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    K983924 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
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    K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMS
    K974463 IMMUNO CONCEPTS ANCA TEST SYSTEM
    K963275 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
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    Search all 36 clearances from Immuno Concepts, Inc. →