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

    FIAX HAPTOGLOBIN TEST KIT

    K Number: K843570 · Decision Oct 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    29
    Review Days
    24

    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
    FIAX HAPTOGLOBIN TEST KIT
    K Number
    K843570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5460
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    September 11, 1984
    Decision Date
    October 5, 1984
    Product Code
    DAB
    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
    DAB Haptoglobin, Fitc, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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

    HAPTOGLOBIN IMMUNOLOGICAL TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN

    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
    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
    K833984 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
    K832821 FIAX IGG TEST
    Search all 29 clearances from Intl. Diagnostic Technology →