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

    CITRISOL ACID CONCENTRATE

    K Number: K130511 · Decision Feb 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    10
    Review Days
    348

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    Basic Information

    Device Name
    CITRISOL ACID CONCENTRATE
    K Number
    K130511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diasol, Inc.
    Date Received
    February 27, 2013
    Decision Date
    February 10, 2014
    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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    Other Clearances by Diasol, Inc.

    K Number Device Name
    K020231 DIASOL-ADDITIVES
    K020230 DIASOL-BICARB
    K011004 NEEDLELOK HYPODERMIC NEEDLE PROTECTION
    K010958 FISTULOK FISTULA NEEDLE PROTECTION
    K011003 SAFESTING AND SAFESTING HUB
    K993187 SHELLY PROTECTED AV FISTULA NEEDLE
    K992999 DAISY PROTECTED SCALP VEIN SET
    K992653 SHELLY PROTECTED AV FISTULA NEEDLE
    K993212 DRYASOL ACID CONCENTRATE MIX