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

    ANTINUCLEAR ANTIBODY IMMUNOLOGICAL

    K Number: K833984 · Decision Jan 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    48

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
    K Number
    K833984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    November 17, 1983
    Decision Date
    January 4, 1984
    Product Code
    KTL
    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
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KTL), ordered by most recent decision date.

    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

    FDA 510(k)
    FDA Class 2 ·Immunology

    Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

    FDA 510(k)
    FDA Class 2 ·Immunology

    NOVA Lite DAPI dsDNA Crithidia luciliae Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern

    FDA 510(k)
    FDA Class 2 ·Immunology

    RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Intl. Diagnostic Technology

    K Number Device Name
    K850591 FIAX TOXO-M ANTIBODIES TEST KIT
    K843570 FIAX HAPTOGLOBIN TEST KIT
    K843621 FIAX 420 DILUTOR
    K843356 FIAX 100 FLUOROMETER
    K842749 FIAX TOTAL IGE TEST KIT
    K842071 FIAX TRANSFERRIN TEST KIT
    K841174 RUBELLA ANTIBODY FLUOROIMMUNOASSAY
    K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
    K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
    K832821 FIAX IGG TEST
    Search all 29 clearances from Intl. Diagnostic Technology →