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

    DIASCREEN REAGENT STRIPS

    K Number: K981555 · Decision Jun 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    31

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    Basic Information

    Device Name
    DIASCREEN REAGENT STRIPS
    K Number
    K981555
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.7675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chronimed, Inc.
    Date Received
    May 1, 1998
    Decision Date
    June 1, 1998
    Product Code
    LJX
    Advisory Committee
    Hematology
    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
    LJX Test, Urine Leukocyte

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    Other Clearances by Chronimed, Inc.

    K Number Device Name
    K010039 QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION
    K983432 SUPREME II CONTROL SOLUTIONS
    K980573 SENSOREX BLOOD GLUCOSE MONITORING SYSTEM
    K963544 SUPREME II METER