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Found 8 results
510(k) Data Aggregation
K Number
K031267Device Name
STERICHEK BICARB PH REAGENT STRIPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
2003-12-23
(246 days)
Product Code
MNV
Regulation Number
876.5820Why 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.
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K Number
K003615Device 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
876.5820Why did this record match?
Applicant Name (Manufacturer) :
ENVIRONMENTAL TEST SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001194Device Name
STERICHEK TOTAL CHLORINE REAGENT STRIPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
2000-07-11
(90 days)
Product Code
MSY
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
ENVIRONMENTAL TEST SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994226Device Name
STERICHEK TOTAL CHLORINE REAGENT STRIPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
2000-03-22
(98 days)
Product Code
MSY
Regulation Number
876.5665Why 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.
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K Number
K983997Device Name
STERICHEK TOTAL CHLORINE TEST KIT
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
1999-04-02
(143 days)
Product Code
MSY
Regulation Number
876.5665Why 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).
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K Number
K980164Device Name
STERICHEK PERACETIC ACID REAGENT STRIPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
1998-04-16
(90 days)
Product Code
MSY
Regulation Number
876.5665Why 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.
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K Number
K974798Device Name
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
1998-03-20
(88 days)
Product Code
LIF
Regulation Number
876.5820Why 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.
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K Number
K971598Device Name
STERICHEK CHLORINE REAGENT STRIPS
Manufacturer
ENVIRONMENTAL TEST SYSTEMS, INC.
Date Cleared
1997-07-18
(78 days)
Product Code
MSY
Regulation Number
876.5665Why 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.
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