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

    ANTI-DSDNA ANTIBODY TEST

    K Number: K913041 · Decision Nov 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    15
    Review Days
    119

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    Basic Information

    Device Name
    ANTI-DSDNA ANTIBODY TEST
    K Number
    K913041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helix Diagnostics, Inc.
    Date Received
    July 9, 1991
    Decision Date
    November 5, 1991
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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    Other Clearances by Helix Diagnostics, Inc.

    K Number Device Name
    K001900 ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
    K000489 ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
    K980337 DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
    K960091 ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
    K954700 ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
    K954723 ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
    K952253 ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
    K951850 ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
    K951798 ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
    K940510 ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
    Search all 15 clearances from Helix Diagnostics, Inc. →