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

    DIASCREEN REAGENT STRIPS

    K Number: K971976 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    DIASCREEN REAGENT STRIPS
    K Number
    K971976
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.7675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dia-Screen Corp.
    Date Received
    May 29, 1997
    Decision Date
    June 17, 1997
    Product Code
    LJX
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    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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