BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    RF-LATEX SEIKEN REAGENT SYSTEM

    K Number: K960703 · Decision Apr 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    2
    Review Days
    59

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    Basic Information

    Device Name
    RF-LATEX SEIKEN REAGENT SYSTEM
    K Number
    K960703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Globe Management Support, Inc.
    Date Received
    February 20, 1996
    Decision Date
    April 19, 1996
    Product Code
    DHR
    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
    DHR System, Test, Rheumatoid Factor

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    Other Clearances by Globe Management Support, Inc.

    K Number Device Name
    K960702 CRP-LATEX SEIKEN XR REAGENT SYSTEM