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510(k) Data Aggregation

    K Number
    K031392
    Device Name
    MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2003-07-01

    (60 days)

    Product Code
    DKC
    Regulation Number
    862.3280
    Why did this record match?
    Product Code :

    DKC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
    Device Description
    Not Found
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