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

    SERA FOR ANTINUCLEAR ANTIBODIES

    K Number: K820945 · Decision Oct 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    30
    Review Days
    203

    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
    SERA FOR ANTINUCLEAR ANTIBODIES
    K Number
    K820945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Centers for Disease Control and Prevention
    Date Received
    April 6, 1982
    Decision Date
    October 26, 1982
    Product Code
    DHN
    Advisory Committee
    Immunology
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

    Similar 510(k) Clearances

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

    Zeus IFA ANA HEp-2 Test System, Zeus dIFine

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuGlo HEp-2 Elite IFA

    FDA 510(k)
    FDA Class 2 ·Immunology

    AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Image Navigator by Immuno Concepts

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Immunology

    NOVA Lite DAPI ANA Kit

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

    Other Clearances by Centers for Disease Control and Prevention

    K Number Device Name
    K260812 Francisella tularensis Real-time PCR Assay
    K252072 Francisella tularensis Real-time PCR assay
    K243274 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K243931 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
    K241110 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
    K222558 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221834 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K221658 Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
    K200370 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
    K192871 B. anthracis Real-time PCR Assay
    Search all 30 clearances from Centers for Disease Control and Prevention →