Data / Medical devices / Ireland / Waters Technologies Ireland, Ltd.
Waters Technologies Ireland, Ltd.: FDA-registered device maker in DRINAGH Wexford, Ireland, 1 510(k) clearance
Waters Technologies Ireland, Ltd. is registered with the FDA (registration 9616673) in DRINAGH Wexford, Ireland. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 25, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616673
- FEI number
- 3003179344
- Address
- Wexford Business Park, DRINAGH Wexford, Ireland, --
- Owner or operator
- WATERS CORPORATION (1218959)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 25, 1998
- Registered through
- 2026
- Brand names listed
- ACQUITY BEH, ACQUITY BEH Phenyl, ACQUITY HSS T3, ACQUITY TQD, MASS TRAK IMMUNOSUPPRESSANTS KIT, MASS TRAK KIT CALIBRATOR, MASS TRAK KIT QUALITY CONTROL, MASSTRAK C18 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Specification developer | accessdata.fda.gov |
| Columns, Liquid Chromatography | DPM | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Tracrolimus | MLM | 2 | Specification developer | accessdata.fda.gov |
| Mass Spectrometer, Clinical Use | DOP | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 25, 2007 | K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | MLM | Substantially Equivalent | Waters Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Enzyme Immunoassay, Tracrolimus
- All makers of Calibrator, Secondary
- All makers of Columns, Liquid Chromatography
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
Updated May 25, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.