Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616673

FEI Number

3003179344

Entity Name

WATERS TECHNOLOGIES IRELAND, LTD.

City/State/Country

DRINAGH Wexford, IE

Establishment Address

WEXFORD BUSINESS PARK, DRINAGH Wexford --, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

WATERS CORPORATION (Owner Number: 1218959)

Owner / Operator Contact Address

34 Maple Street, Milford, MA 01757, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MASSTRAK C18 ACQUITY BEH ACQUITY HSS T3 ACQUITY BEH Phenyl MASS TRAK IMMUNOSUPPRESSANTS KIT MASS TRAK KIT CALIBRATOR MASS TRAK KIT QUALITY CONTROL MassTrak Immunosuppressant Quality Control Set MassTrak Steroid Serum QC Set 1 MassTrak Steroid Serum QC Set 3 MassTrak Steroid Serum QC Set 2 MassTrak Steroid Serum Cal Set 1 MassTrak Immunosuppressant Calibrator Set MassTrak Immunosuppressant Internal Standard Set MassTrak Endocrine Blank Calibrator MassTrak Steroid Serum Cal Set 3 MassTrak Steroid Internal Standard Mix MassTrak Steroid Serum Cal Set 2 MassTrak Steroid Optimization Mix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPM	Columns, Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	1998-09-25
MLM	Enzyme Immunoassay, Tracrolimus	Clinical Chemistry	Class 2	862.1678	2007-07-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-07-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-07-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2021-10-19
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2021-10-19

Official Correspondent

Raajdeep Venkatesan

US Agent Details

Meghan Oliveira Business: Waters Corporation Email: Regulatory@waters.com Phone: (508) 4822000

Related Public Records

Same Entity

WATERS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1218959	WATERS CORPORATION	MILFORD, MA, US
3000221947	WATERS TECHNOLOGIES CORPORATION	WILMSLOW Manchester, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

Similar Registrations

Registration Number	Establishment Name	Location
9614673	HITACHI HIGH-TECH CORP., NAKA DIVISION	Hitachinaka-shi Ibaraki, JP
1218959	WATERS CORPORATION	MILFORD, MA, US
3006397327	SPARK HOLLAND BV.	EMMEN Drenthe, NL
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616673. Last updated year: 2026. Please use registration number 9616673 when referencing this establishment in official correspondence.