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

    FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208

    K Number: K060774 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    63
    Applicant Total
    270
    Review Days
    30

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    Basic Information

    Device Name
    FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
    K Number
    K060774
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1295
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    March 22, 2006
    Decision Date
    April 21, 2006
    Product Code
    CGN
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGN Acid, Folic, Radioimmunoassay

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