BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

    K Number: K980855 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    47

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    Basic Information

    Device Name
    IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
    K Number
    K980855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dpc Cirrus
    Date Received
    March 5, 1998
    Decision Date
    April 21, 1998
    Product Code
    DHX
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DHX System, Test, Carcinoembryonic Antigen

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    Other Clearances by Dpc Cirrus

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