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

    DAU I, DAU II, DAU III AND DAU IV CONTROL URINE

    K Number: K893835 · Decision Jul 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    125
    Review Days
    62

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    Basic Information

    Device Name
    DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
    K Number
    K893835
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    May 24, 1989
    Decision Date
    July 25, 1989
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    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
    DIF Drug Mixture Control Materials

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