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

    FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

    K Number: K052082 · Decision Aug 19, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    23
    Applicant Total
    270
    Review Days
    17

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    Basic Information

    Device Name
    FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
    K Number
    K052082
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    August 2, 2005
    Decision Date
    August 19, 2005
    Product Code
    JMG
    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
    JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

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