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

    ACON URINALYSIS REAGENT STRIPS

    K Number: K061559 · Decision Aug 11, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    8
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    ACON URINALYSIS REAGENT STRIPS
    K Number
    K061559
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1785
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acon Laboratories Co.
    Date Received
    June 5, 2006
    Decision Date
    August 11, 2006
    Product Code
    CDM
    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
    CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

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