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

    DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE

    K Number: K022500 · Decision Dec 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    5
    Review Days
    147

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    Basic Information

    Device Name
    DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
    K Number
    K022500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rockwell Medical Technologies, Inc.
    Date Received
    July 29, 2002
    Decision Date
    December 23, 2002
    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 Rockwell Medical Technologies, Inc.

    K Number Device Name
    K062399 ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
    K023985 ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE
    K022521 BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON
    K983618 DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE