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

    FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS

    K Number: K953672 · Decision Jul 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    329

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    Basic Information

    Device Name
    FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
    K Number
    K953672
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1510
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymer Technology Intl.
    Date Received
    August 7, 1995
    Decision Date
    July 1, 1996
    Product Code
    JMT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)

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