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

    KODAK SURECELL CHLAMYDIA TEST KIT

    K Number: K882923 · Decision Nov 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    238
    Review Days
    120

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    Basic Information

    Device Name
    KODAK SURECELL CHLAMYDIA TEST KIT
    K Number
    K882923
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    July 13, 1988
    Decision Date
    November 10, 1988
    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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