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

    X-ACT UREA/TDA

    K Number: K883995 · Decision Oct 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    52
    Applicant Total
    27
    Review Days
    22

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    Basic Information

    Device Name
    X-ACT UREA/TDA
    K Number
    K883995
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pro-Lab, Inc.
    Date Received
    September 20, 1988
    Decision Date
    October 12, 1988
    Product Code
    JSE
    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
    JSE Culture Media, Multiple Biochemical Test

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