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

    LITH A TEST TM

    K Number: K830091 · Decision Feb 15, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    35

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    Basic Information

    Device Name
    LITH A TEST TM
    K Number
    K830091
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lenal Creative Approaches, Inc.
    Date Received
    January 11, 1983
    Decision Date
    February 15, 1983
    Product Code
    CEN
    Advisory Committee
    Clinical Chemistry
    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
    CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)

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