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

    EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

    K Number: K021781 · Decision Aug 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    92

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    Basic Information

    Device Name
    EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
    K Number
    K021781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chay Medical, LLC
    Date Received
    May 30, 2002
    Decision Date
    August 30, 2002
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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    Other Clearances by Chay Medical, LLC

    K Number Device Name
    K013342 EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.