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

    STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

    K Number: K003615 · Decision Feb 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    49
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
    K Number
    K003615
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Environmental Test Systems, Inc.
    Date Received
    November 22, 2000
    Decision Date
    February 1, 2001
    Product Code
    FKP
    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
    FKP System, Dialysate Delivery, Single Patient

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