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510(k) Data Aggregation

    K Number
    K990507
    Device Name
    ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
    Manufacturer
    ALTHIN BIOPHARM, INC.
    Date Cleared
    1999-05-07

    (78 days)

    Product Code
    KPO
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    This concentrate is formulated to be used with a two stream hemodialysis machine calibrated to an acetate concentrate dilution ratio of 1:34.

    Device Description

    Dialysate Bicarbonate Concentrate (Liquid and Powder)
    Dialysate Acid Concentrate (Liquid and Powder)
    Dialysate Acetate Concentrate (Liquid and Powder)

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the question as it does not contain information regarding the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for "Dialysate Concentrate For Hemodialysis (Liquid and Powder)", indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls but does not include performance study details.

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