BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

    K Number: K914953 · Decision Feb 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    106

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    Basic Information

    Device Name
    IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
    K Number
    K914953
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stellar Bio Systems, Inc.
    Date Received
    November 5, 1991
    Decision Date
    February 19, 1992
    Product Code
    LKI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKI Antisera, Fluorescent, Chlamydia Spp.

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    K990915 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
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    K900974 INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
    K882835 INDIRECT FLUORESCENT ASSAY FOR (HCMV)