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

    VIDAS CHLAMYDIA ASSAY, MODIFICATION

    K Number: K915884 · Decision Mar 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    39
    Review Days
    83

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    Basic Information

    Device Name
    VIDAS CHLAMYDIA ASSAY, MODIFICATION
    K Number
    K915884
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitek Systems, Inc.
    Date Received
    December 12, 1991
    Decision Date
    March 4, 1992
    Product Code
    LJC
    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
    LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

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