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

    HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER

    K Number: K012328 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    6
    Review Days
    179

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    Basic Information

    Device Name
    HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
    K Number
    K012328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Di-Chem, Inc.
    Date Received
    July 23, 2001
    Decision Date
    January 18, 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 Di-Chem, Inc.

    K Number Device Name
    K202508 Hemo-Lyte C Cartridge
    K171015 Citryte
    K012547 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
    K905217 FORMASURE TEST REAGENT
    K823103 DIALYSATE ADDITIVES-POWDER/LIQUID