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

    ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT

    K Number: K900402 · Decision Mar 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    66
    Applicant Total
    238
    Review Days
    38

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    Basic Information

    Device Name
    ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
    K Number
    K900402
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Eastman Kodak Company
    Date Received
    January 29, 1990
    Decision Date
    March 8, 1990
    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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