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Found 17 results
510(k) Data Aggregation
K Number
K251035Device Name
DISINTEK PA Test Strips
Manufacturer
Serim Research
Date Cleared
2025-06-03
(61 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Serim Research
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim™ DISINTEK™ PA Test Strip is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in the high-level disinfectant RAPICIDE™ PA HLD solution, is above the 850 ppm PAA minimum recommended concentration (MRC) established for RAPICIDE™ PA HLD at both 30°C and 20°C.
Device Description
The device is a qualitative, single use, reagent chemical indicator made up of a 0.2-inch x 0.2-inch indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration established for RAPICIDE™ PA High-Level Disinfectant. The indicator pad is affixed to one end of a 3.25-inch by 0.2-inch white plastic handle.
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K Number
K202565Device Name
WAVICIDE-OPA MEC Indicator
Manufacturer
Serim Research Corporation
Date Cleared
2020-12-02
(89 days)
Product Code
JOJ, FXX
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Serim Research Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
Device Description
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
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K Number
K192445Device Name
QwikCheck Chemical Indicators
Manufacturer
Serim Research Corporation
Date Cleared
2020-04-02
(209 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
Serim Research Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm.
Device Description
The device is a qualitative, single use, reagent chemical indicator made up of a 0.20-inch square indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration. The indicator pad is affixed to one end of a 3.25 inch by 0.20-inch white opaque plastic handle.
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K Number
K120652Device Name
RAPICIDE OPA-28 TEST STRIP
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2012-10-12
(224 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RAPICIDE OPA-28 Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in RAPICIDE OPA-28 Solution, is above or below the established Minimum Recommended Concentration (MRC) of 0.35%.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square indicator pad that has been chemically treated to detect OPA. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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K Number
K092346Device Name
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2010-01-07
(156 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim® D-CIDE GTA 1.5% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in Rapicide HLD and Sterilant (Medivators Reprocessing Systems), is above or at/below the minimum effective concentration (MEC) of 1.5% GTA established for this solution.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square indicator pad that has been chemically treated to detect GTA. 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
K083295Device Name
SERIM DISINTEK GTA 2.1%, MODEL: 5164
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2009-03-16
(126 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim® Disintek GTA 2.1% Test Strip is a chemical indicator for use in determining whether the concentration of glutaraldehyde, the active ingredient in CIDEXPLUS 28 Day Solution, is above or below the minimum effective concentration (MEC) established for CIDEXPLUS 28 Day Solution.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40-inch square reagent pad that has been chemically treated to detect glutaraldehyde in CIDEXPLUS 28 Day solutions. The pad is affixed to one end of a 3.25 inch by 0.40-inch white opaque polystyrene strip.
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K Number
K082352Device Name
SERIM DISINTEK OPA TEST STRIP
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2008-09-25
(40 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Metricidc OPA Plus Solution, is above or below the minimum effective concentration (MEC) established for Metricide OPA Plus Solution.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Metricide OPA Plus Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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K Number
K081370Device Name
SERIM DISINTEK OPA TEST STRIP
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2008-07-11
(57 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Cidex OPA Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
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K Number
K080712Device Name
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2008-05-06
(54 days)
Product Code
MSY
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SERIM® HiSENSE ULTRA 0.1 TM Test Strips provide a convenient means for indicating the concentration of residual chlorine (chlorine bleach) detected in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment. HiSENSE ULTRA 0.1 also provides a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in water used to prepare dialysate.
Device Description
The device is a semi-quantitative or qualitative, single use, reagent test strip made up of a 0.20 inch square reagent pad that has been chemically treated to detect total chlorine (free chlorine/chloramines) 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
K052388Device Name
SERIM PERACETIC ACID CHEMICAL INDICATOR
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2005-12-01
(92 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
SERIM RESEARCH CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.
Device Description
The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square purple reagent pad that has been chemically treated to detect the active ingredient in the Steris 20™ Sterilant® when used in the STERIS SYSTEM 1® Processor™. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
The Serim* Peracetic Acid Chemical Indicator is configured as a paper pad on a plastic strip support. A dve in the chemical indicator pad is oxidized (bleached) by the use solution. The extent of bleaching indicates whether a sufficient concentration active agent (peracetic acid) was present. At the end of the processing evele the user compares the reacted indicator to a color chart composed of two color blocks. The "START" color block is similar to the unreacted indicator strip. The =COMPLETE color block is similar to an indicator strip that has been exposed to peracetic acid at or above a concentration of 1500 ppm.
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