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

    FIRST CHOICE KETONES URINE TEST STRIPS

    K Number: K953662 · Decision Jun 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    312

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    Basic Information

    Device Name
    FIRST CHOICE KETONES URINE TEST STRIPS
    K Number
    K953662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1435
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymer Technology Intl.
    Date Received
    August 7, 1995
    Decision Date
    June 14, 1996
    Product Code
    JIN
    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
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

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    Other Clearances by Polymer Technology Intl.

    K Number Device Name
    K953672 FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
    K953661 FIRST CHOICE GLUCOSE URINE TEST STRIPS
    K953680 FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
    K946166 FIRST CHOICE(TM) TEST STRIP
    K950628 FIRST CHOICE TEST STRIP