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510(k) Data Aggregation

    K Number
    K960777
    Device Name
    MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
    Manufacturer
    MDT CORP., INC.
    Date Cleared
    1996-05-23

    (87 days)

    Product Code
    FRC
    Regulation Number
    880.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDT CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
    Device Description
    A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.
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