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

    RA SCREENING TEST

    K Number: K830611 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    8
    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
    RA SCREENING TEST
    K Number
    K830611
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Tago, Inc.
    Date Received
    February 28, 1983
    Decision Date
    March 24, 1983
    Product Code
    DHR
    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
    DHR System, Test, Rheumatoid Factor

    Similar 510(k) Clearances

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

    K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA RF IgM Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    Optilite Rheumatoid Factor Kit

    FDA 510(k)
    FDA Class 2 ·Immunology

    Rheumatoid Factor (RF) Kit for use on SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA

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

    Other Clearances by Tago, Inc.

    K Number Device Name
    K841734 TAGO FIFFU-GEN, OROSOMUCOID
    K841265 TAGO DIFFU-GEN C-REACTIVE PROTEIN
    K834218 DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
    K840404 DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
    K833129 TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
    K830531 MONO SCREENING TEST
    K830156 HCG SCREENING TEST