LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K210481
    Device Name
    Instant 20s Indicator
    Manufacturer
    True Indicating LLC
    Date Cleared
    2021-12-14

    (298 days)

    Product Code
    MTC
    Regulation Number
    880.2800
    Why did this record match?
    Product Code :

    MTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The True Indicating Instant 20s Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at: 121°C, 30 minutes (Gravity), 132°C, 4 minutes (Pre- Vacuum), 135°C, 3 minutes (Pre-Vacuum).
    Device Description
    The True Indicating Instant 20s Indicator consists of a polycarbonate vial, polypropylene cap, a silicone vented cap which serves as a base, a vinyl sealant, and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953.
    Ask a Question

    Ask a specific question about this device

    K Number
    K962649
    Device Name
    SPORTROL RAPID STERILITY INDICATOR
    Manufacturer
    NORTH AMERICAN SCIENCE ASSOC., INC.
    Date Cleared
    1997-09-26

    (445 days)

    Product Code
    MTC
    Regulation Number
    880.2800
    Why did this record match?
    Product Code :

    MTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.
    Device Description
    RSI, Rapid Indicator
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1