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510(k) Data Aggregation

    K Number
    K133549
    Device Name
    STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    Manufacturer
    STERITEC PRODUCTS MFG., CO., INC.
    Date Cleared
    2014-08-27

    (281 days)

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

    STERITEC PRODUCTS MFG., CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SteriTec Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
    Device Description
    The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
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    K Number
    K133322
    Device Name
    STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
    Manufacturer
    STERITEC PRODUCTS MFG., CO., INC.
    Date Cleared
    2014-08-25

    (300 days)

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

    STERITEC PRODUCTS MFG., CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
    Device Description
    The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.
    Ask a Question

    Ask a specific question about this device

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