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

    Citric Complete Liquid Citric Acid Concentrate

    K Number: K223431 · Decision Aug 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    2
    Review Days
    263

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    Basic Information

    Device Name
    Citric Complete Liquid Citric Acid Concentrate
    K Number
    K223431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nipro Renal Solutions USA, Corp.
    Date Received
    November 14, 2022
    Decision Date
    August 4, 2023
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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    NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)

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    Other Clearances by Nipro Renal Solutions USA, Corp.

    K Number Device Name
    K193155 Nipro Dry Complete Dry Acid Concentrate for Hemodialysis