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

    INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY

    K Number: K990915 · Decision Apr 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
    K Number
    K990915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stellar Bio Systems, Inc.
    Date Received
    March 18, 1999
    Decision Date
    April 21, 1999
    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

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    K914953 IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
    K905608 INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
    K900974 INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
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