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

    UREA AGAR

    K Number: K791940 · Decision Oct 30, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    284
    Applicant Total
    93
    Review Days
    29

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    Basic Information

    Device Name
    UREA AGAR
    K Number
    K791940
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Isle Media and Sterile Products, Inc.
    Date Received
    October 1, 1979
    Decision Date
    October 30, 1979
    Product Code
    JSI
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JSI Culture Media, Selective And Differential

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