BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    DIASLIDE URINE CULTURING DEVICE

    K Number: K921045 · Decision Sep 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    5
    Review Days
    208

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    Basic Information

    Device Name
    DIASLIDE URINE CULTURING DEVICE
    K Number
    K921045
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Savyon Diagnostics , Ltd.
    Date Received
    March 4, 1992
    Decision Date
    September 28, 1992
    Product Code
    JXA
    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
    JXA Kit, Screening, Urine

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