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510(k) Data Aggregation

    K Number
    K002011
    Device Name
    GLUTARTEST 1 REAGENT STRIP
    Manufacturer
    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
    Date Cleared
    2001-01-22

    (203 days)

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

    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964264
    Device Name
    HIGH RANGE PEROXIDE TEST STRIP
    Manufacturer
    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
    Date Cleared
    1997-06-16

    (234 days)

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

    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Range Peroxide™ Test Strip is intended for use as an efficacy test strip for measuring effective levels of peroxide in Renalin® disinfectant solution. Each time when the kidney unit is reprocessed with peroxide disinfectant solution such as Renalin® , the reprocessing solution should be monitored with the High Range Peroxide™ Test Strip to assure that Renaline concentration is 3% as it is intended to be. After the kidney is placed under storage until next use, the Renaling concentration in the disinfectant solution should be checked again before rinsing with the strip to assure that Renalins concentration has been maintained at 1% or higher. If the Renaling concentration drops below 1%, the kidney unit has to be either reprocessed or discarded.
    Device Description
    High Range Peroxide™ Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. It is a self-contained, ready to use dip-andread reagent strip without additional reagent. The strip is packaged in 50 or 100's in bottles. Color blocks corresponding to Renalin8 concentrations of 0.2, 0.5, 1.0, 2.0 and 3.0 % are printed on the bottle label. Quantitative estimation of Renalink concentration can be made by comparing the strip color to the color blocks.
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    K Number
    K953854
    Device Name
    WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
    Manufacturer
    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.
    Date Cleared
    1996-03-11

    (217 days)

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

    INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WaterCleck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.
    Device Description
    WaterCleck™ CP Reagent Strip is a paper based dry chemistry reagent strip. It consists of a single reagent pad, 0.2x0.2 inch square, adhered to one end of a 0.2x2.5 inch plastic handle with a double sided adhesive. The chemistry of the regent strip allows the same single reagent pad to react with either chlorine or peroxide. It is self-contained and is ready to use as a dip-and-read reagent strip without other additional reagent.
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