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

    GUARDIAN™ Quick Dip Residual Chlorine (5212)

    K Number: K253863 · Decision Mar 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    104

    Basic Information

    Device Name
    GUARDIAN™ Quick Dip Residual Chlorine (5212)
    K Number
    K253863
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serim Research
    Date Received
    December 3, 2025
    Decision Date
    March 17, 2026
    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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