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

    ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

    K Number: K001935 · Decision Aug 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    270
    Review Days
    57

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    Basic Information

    Device Name
    ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
    K Number
    K001935
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    June 26, 2000
    Decision Date
    August 22, 2000
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

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