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

    FERR FLEX REAGENT CARTRIDGE

    K Number: K963498 · Decision Jan 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    23
    Applicant Total
    13
    Review Days
    143

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    Basic Information

    Device Name
    FERR FLEX REAGENT CARTRIDGE
    K Number
    K963498
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Chemistry Systems, Inc.
    Date Received
    September 3, 1996
    Decision Date
    January 24, 1997
    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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