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

    LACTIC ACID DIALYSATE ADDITIVE

    K Number: K811706 · Decision Sep 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    3
    Review Days
    100

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    Basic Information

    Device Name
    LACTIC ACID DIALYSATE ADDITIVE
    K Number
    K811706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Edlaw Pharmaceuticals, Inc.
    Date Received
    June 16, 1981
    Decision Date
    September 24, 1981
    Product Code
    KPO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    CH
    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 Edlaw Pharmaceuticals, Inc.

    K Number Device Name
    K833896 BICARBOLYTE HEMO-DIAL
    K813388 HEMODIALYSATE