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

    ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

    K Number: K981985 · Decision Sep 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    27
    Applicant Total
    270
    Review Days
    111

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    Basic Information

    Device Name
    ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
    K Number
    K981985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    June 5, 1998
    Decision Date
    September 24, 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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