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510(k) Data Aggregation

    K Number
    K063868
    Device Name
    MASSTRAK IMMUNOSUPPRESSANTS KIT
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    2007-05-25

    (147 days)

    Product Code
    MLM, JIT, JJX
    Regulation Number
    862.1678
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Waters MassTrak Immunosuppressants Kit is indicated for the quantification of the immunosuppressive drug Tacrolimus (FK506; Prograf) in liver and kidney transplant patient whole blood samples for the purposes of monitoring drug levels to direct subsequent patient dosing.
    Device Description
    The MassTrak Immunosuppressants Kit for Tacrolimus is an in vitro medical device intended to facilitate quantitative determination of Tacrolimus in human whole blood as an aid in the management of kidney and liver transplant patients receiving Tacrolimus drug therapy. The components of the kit are intended for use with an LC/MS/MS system. The kit materials - calibrators, quality control materials, internal standards, and neat solutions, as well as a MassTrakTM 2.1 x 10 mm C18 cartridge column - have been optimized for use with the Waters Quattro micro and Alliance 2795 System, but can be used with any LC/MS/MS configuration optimized for quantification.
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    K Number
    K980180
    Device Name
    2700 SAMPLE MANAGER
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1998-02-12

    (23 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials. This product is-intended for In Vitro Diagnostic Use.
    Device Description
    The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials.
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    K Number
    K973074
    Device Name
    2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1997-10-06

    (49 days)

    Product Code
    KZR
    Regulation Number
    862.2260
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals. The product is not intended exclusively for clinical use. In using this product, the operator must follow generally accepted procedures for quality control and methods development.
    Device Description
    Waters® 2487 Tunable Dual Wavelenqth Absorbance Dectector
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    K Number
    K964588
    Device Name
    WATERS 515 HPLC PUMP (515)
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1996-11-29

    (14 days)

    Product Code
    KIE
    Regulation Number
    862.2260
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962574
    Device Name
    WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1996-07-22

    (21 days)

    Product Code
    LEQ
    Regulation Number
    862.2260
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961557
    Device Name
    ALLIANCE 2690 SEPARATIONS MODULE
    Manufacturer
    WATERS CORPORATION
    Date Cleared
    1996-07-05

    (74 days)

    Product Code
    LDM
    Regulation Number
    862.2260
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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