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

    RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

    K Number: K895997 · Decision Nov 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    15
    Review Days
    24

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    Basic Information

    Device Name
    RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
    K Number
    K895997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Lipogen, Inc.
    Date Received
    October 13, 1989
    Decision Date
    November 6, 1989
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Lipogen, Inc.

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    K895994 RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES
    K894659 ANA ANTISERA CONTROL KIT
    K892421 MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
    K885048 ACCESS R-CLONE ANA PROFILE ASSAY
    K882740 ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
    K880254 SM ANTIBODY TEST KIT
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