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

    QUANTIMETRIX URINE DIPSTICK CONTROL

    K Number: K874890 · Decision Jan 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    60
    Applicant Total
    8
    Review Days
    51

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    Basic Information

    Device Name
    QUANTIMETRIX URINE DIPSTICK CONTROL
    K Number
    K874890
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    December 1, 1987
    Decision Date
    January 21, 1988
    Product Code
    JJW
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

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    K873011 QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
    K873467 QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
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