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

    ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM

    K Number: K911661 · Decision Dec 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    36
    Review Days
    241

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    Basic Information

    Device Name
    ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
    K Number
    K911661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immuno Concepts, Inc.
    Date Received
    April 12, 1991
    Decision Date
    December 9, 1991
    Product Code
    MID
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MID System, Test, Anticardiolipin Immunological

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    Other Clearances by Immuno Concepts, Inc.

    K Number Device Name
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    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. →