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

    RIA KIT, FERRITIN SOLID PHASE

    K Number: K781946 · Decision Jan 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    23
    Applicant Total
    632
    Review Days
    50

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    Basic Information

    Device Name
    RIA KIT, FERRITIN SOLID PHASE
    K Number
    K781946
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    November 21, 1978
    Decision Date
    January 10, 1979
    Product Code
    JMG
    Advisory Committee
    Immunology
    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
    JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

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