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

    GLUTARTEST 1 REAGENT STRIP

    K Number: K002011 · Decision Jan 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    3
    Review Days
    203

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    Basic Information

    Device Name
    GLUTARTEST 1 REAGENT STRIP
    K Number
    K002011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Integrated Biomedical Technology, Inc.
    Date Received
    July 3, 2000
    Decision Date
    January 22, 2001
    Product Code
    MSY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

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    Other Clearances by Integrated Biomedical Technology, Inc.

    K Number Device Name
    K964264 HIGH RANGE PEROXIDE TEST STRIP
    K953854 WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE