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

    MICRO21 WITH NDNA

    K Number: K964165 · Decision Jan 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    78

    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
    MICRO21 WITH NDNA
    K Number
    K964165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triangle Biomedical Sciences, Inc.
    Date Received
    October 17, 1996
    Decision Date
    January 3, 1997
    Product Code
    DHN
    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
    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 Triangle Biomedical Sciences, Inc.

    K Number Device Name
    K982301 MICRO21 WITH URINE SEDIMENT ANALYSIS
    K973050 MICRO21 WITH WBC ESTIMATE
    K971470 MICRO21 WITH CEREBROSPINAL FLUID
    K960774 MICRO21 WITH ANA
    K960776 MICRO21 WITH RETIC