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

    URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

    K Number: K912888 · Decision Feb 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    238

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    Basic Information

    Device Name
    URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
    K Number
    K912888
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dynagen, Inc.
    Date Received
    July 1, 1991
    Decision Date
    February 24, 1992
    Product Code
    MIG
    Advisory Committee
    Unknown
    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
    MIG Strip, Test Isoniazid

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