BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHARISE CHARLES REAGENT STRIPS

    K Number: K895282 · Decision Jan 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    139

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    Basic Information

    Device Name
    CHARISE CHARLES REAGENT STRIPS
    K Number
    K895282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Lee Import Domestic Consulting
    Date Received
    August 24, 1989
    Decision Date
    January 10, 1990
    Product Code
    JIL
    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
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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    Other Clearances by Lee Import Domestic Consulting

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