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

    SERIM RESIDUAL CHLORINE TEST KIT

    K Number: K901734 · Decision Sep 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    27
    Review Days
    149

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    Basic Information

    Device Name
    SERIM RESIDUAL CHLORINE TEST KIT
    K Number
    K901734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Serim Research Corp.
    Date Received
    April 17, 1990
    Decision Date
    September 13, 1990
    Product Code
    FKJ
    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
    FKJ Filter, Blood, Dialysis

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