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

    I.D. AND SEAKEM GTG AGAROSES

    K Number: K940037 · Decision Feb 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    416

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    Basic Information

    Device Name
    I.D. AND SEAKEM GTG AGAROSES
    K Number
    K940037
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4900
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fmc Corp.
    Date Received
    January 4, 1994
    Decision Date
    February 24, 1995
    Product Code
    JZR
    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
    JZR Support Gels

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