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

    ACCESS DHEA-S REAGENT ASSAY

    K Number: K040181 · Decision Mar 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    27
    Applicant Total
    270
    Review Days
    57

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    Basic Information

    Device Name
    ACCESS DHEA-S REAGENT ASSAY
    K Number
    K040181
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    862.1245
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    January 27, 2004
    Decision Date
    March 24, 2004
    Product Code
    JKC
    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
    JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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