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

    QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA

    K Number: K893896 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    45

    Basic Information

    Device Name
    QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
    K Number
    K893896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    BIOSTAR MEDICAL PRODUCTS, INC.
    Date Received
    May 30, 1989
    Decision Date
    July 14, 1989
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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    Other Clearances by BIOSTAR MEDICAL PRODUCTS, INC.

    K Number Device Name
    K893897 SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
    K863238 READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
    K861499 BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
    K853697 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT