BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST

    K Number: K872056 · Decision Jun 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    20
    Review Days
    18

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    Basic Information

    Device Name
    MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
    K Number
    K872056
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Boots-Celltech Diagnostics, Inc.
    Date Received
    May 28, 1987
    Decision Date
    June 15, 1987
    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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