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510(k) Data Aggregation

    K Number
    K981023
    Device Name
    KLEENASEPTIC
    Manufacturer
    METREX RESEARCH CORP.
    Date Cleared
    1998-04-30

    (42 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Why did this record match?
    Applicant Name (Manufacturer) :

    METREX RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Kleenaseptic is a ready-to-use, spray-on general purpose disinfectant intended for use in cleaning and disinfecting equipment surfaces and non-critical devices in hospitals and other critical care areas where environmental control of cross contamination is important. Kleenaseptic is a disinfectant when used on equipment surfaces and non-critical devices for 10 minutes at room temperature (69°F/20°C).
    Device Description
    Kleenaseptic is a ready-to-use, spray-on isopropyl alcohol/quaternary ammonium general purpose disinfectant used for the cleaning and disinfection of equipment surfaces and non-critical devices prior to terminal sterilization/high-level disinfection in healthcare environments.
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