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510(k) Data Aggregation

    K Number
    K251035
    Device Name
    DISINTEK™ PA Test Strips
    Manufacturer
    Serim Research
    Date Cleared
    2025-06-03

    (61 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K202565
    Device Name
    WAVICIDE-OPA MEC Indicator
    Manufacturer
    Serim Research Corporation
    Date Cleared
    2020-12-02

    (89 days)

    Product Code
    JOJ, FXX
    Regulation Number
    880.2800
    Why 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
    K192445
    Device Name
    QwikCheck Chemical Indicators
    Manufacturer
    Serim Research Corporation
    Date Cleared
    2020-04-02

    (209 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K120652
    Device Name
    RAPICIDE OPA-28 TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2012-10-12

    (224 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K092346
    Device 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
    880.2800
    Why 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
    K083295
    Device Name
    SERIM DISINTEK GTA 2.1%, MODEL: 5164
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2009-03-16

    (126 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K082352
    Device Name
    SERIM DISINTEK OPA TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-09-25

    (40 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K081370
    Device Name
    SERIM DISINTEK OPA TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2008-07-11

    (57 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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
    K080712
    Device 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
    876.5665
    Why 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
    K052388
    Device Name
    SERIM PERACETIC ACID CHEMICAL INDICATOR
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2005-12-01

    (92 days)

    Product Code
    JOJ
    Regulation Number
    880.2800
    Why 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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