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

    IDEIA PCE CHLAMYDIA

    K Number: K033865 · Decision Jan 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    1
    Review Days
    40

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    Basic Information

    Device Name
    IDEIA PCE CHLAMYDIA
    K Number
    K033865
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dakocytomation, Ltd.
    Date Received
    December 12, 2003
    Decision Date
    January 21, 2004
    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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