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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTHIN BIOPHARM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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)
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