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

    READS RF TEST KIT FOR IGM RHEUMATOID FACTOR

    K Number: K863238 · Decision Oct 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    5
    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
    READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
    K Number
    K863238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biostar Medical Products, Inc.
    Date Received
    August 21, 1986
    Decision Date
    October 8, 1986
    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 Biostar Medical Products, Inc.

    K Number Device Name
    K893896 QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
    K893897 SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
    K861499 BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
    K853697 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT