Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K031267
    Device Name
    STERICHEK BICARB PH REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2003-12-23

    (246 days)

    Product Code
    MNV
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.
    Device Description
    The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.
    Ask a Question
    K Number
    K003615
    Device Name
    STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2001-02-01

    (71 days)

    Product Code
    FKP
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001194
    Device Name
    STERICHEK TOTAL CHLORINE REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2000-07-11

    (90 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994226
    Device Name
    STERICHEK TOTAL CHLORINE REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    2000-03-22

    (98 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek ™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The color that develops in the pad after exposure to the sample according to the directions is compared to a color chart to determine the concentration of total chlorine present in the sample.
    Device Description
    The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the amount of total chlorine present in the sample.
    Ask a Question
    K Number
    K983997
    Device Name
    STERICHEK TOTAL CHLORINE TEST KIT
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1999-04-02

    (143 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek™ Total Chlorine Test Kit provides a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines plus free chlorine) in water used to prepare dialysate. The water sample changes color relative to the amount of total chlorine in the water sample.
    Device Description
    The device consists of utilizing a fixed sample size of powdered reagent with a predetermined water sample volume in a test tube to effect a color reaction in the water sample. The color of the sample is then visually compared to a colormetric comparator to determine the total chlorine level in the sample. The device utilizes a recognized standard method of analysis for determining levels of total chlorine in water according to the Association for the Advancement of Medical Instrumentation (1993 Association for the Advancement of Medical Instrumentation-ANSI/AAMI;RD5-1992).
    Ask a Question
    K Number
    K980164
    Device Name
    STERICHEK PERACETIC ACID REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1998-04-16

    (90 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek™ Peracetic Acid Reagent Strips provide a convenient means for determining the effective levels of peracetic acid in dialyzer reprocessing in hemodialysis.
    Device Description
    The device is made up of a 0.20 inch square faint-yellow reagent pad that has been chemically treated to detect peracetic acid in dialyzer reprocessing mix. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
    Ask a Question
    K Number
    K974798
    Device Name
    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1998-03-20

    (88 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
    Device Description
    The device is made up of a 0.20 square inch off-white reagent pad that is chemically treated to detect peroxide in water. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
    Ask a Question
    K Number
    K971598
    Device Name
    STERICHEK CHLORINE REAGENT STRIPS
    Manufacturer
    ENVIRONMENTAL TEST SYSTEMS, INC.
    Date Cleared
    1997-07-18

    (78 days)

    Product Code
    MSY
    Regulation Number
    876.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVIRONMENTAL TEST SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SteriChek™ Chlorine Reagent Strips provide. a convenient means for measuring the concentration of chlorine bleach remaining in water being used to rinse out dialysate lines following disinfection of hemodialysis equipment.
    Device Description
    The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. SteriChek™ Chlorine Reagent Strips contain syringaldazine, a colorless compound which serves as an indicator, potassium iodide, and a pH buffer. The reagent strips react with both free chlorine and combined chlorine (monochloramines). Free chlorine oxidizes syringaldazine to form a colored oxidation product. Combined chlorine in the form of monochloramines oxidize potassium iodide to iodine which in turn oxidizes syringaldazine to the colored form.
    Ask a Question

    Page 1 of 1