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510(k) Data Aggregation
K Number
K063868Device Name
MASSTRAK IMMUNOSUPPRESSANTS KIT
Manufacturer
WATERS CORPORATION
Date Cleared
2007-05-25
(147 days)
Product Code
MLM, JIT, JJX
Regulation Number
862.1678Why 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
K980180Device Name
2700 SAMPLE MANAGER
Manufacturer
WATERS CORPORATION
Date Cleared
1998-02-12
(23 days)
Product Code
JQW
Regulation Number
862.2750Why 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
K973074Device Name
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
Manufacturer
WATERS CORPORATION
Date Cleared
1997-10-06
(49 days)
Product Code
KZR
Regulation Number
862.2260Why 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
K964588Device Name
WATERS 515 HPLC PUMP (515)
Manufacturer
WATERS CORPORATION
Date Cleared
1996-11-29
(14 days)
Product Code
KIE
Regulation Number
862.2260Why 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
K962574Device Name
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
Manufacturer
WATERS CORPORATION
Date Cleared
1996-07-22
(21 days)
Product Code
LEQ
Regulation Number
862.2260Why 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
K961557Device Name
ALLIANCE 2690 SEPARATIONS MODULE
Manufacturer
WATERS CORPORATION
Date Cleared
1996-07-05
(74 days)
Product Code
LDM
Regulation Number
862.2260Why 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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