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

    LUMAC'S BACTERIURIA SCREENING KIT

    K Number: K810746 · Decision Jul 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    1
    Review Days
    134

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    Basic Information

    Device Name
    LUMAC'S BACTERIURIA SCREENING KIT
    K Number
    K810746
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Lumac
    Date Received
    March 19, 1981
    Decision Date
    July 31, 1981
    Product Code
    JXA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    TX
    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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