Data / Medical devices / United States / Waters Corporation
Waters Corporation: FDA-registered device maker in Milford, MA, United States, 1 510(k) clearance
Waters Corporation is registered with the FDA (registration 1218959) in Milford, MA, United States. It lists 9 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
- 1218959
- Address
- 34 Maple ST, Milford, MA, United States, 01757
- Owner or operator
- WATERS CORPORATION (1218959)
- Roles
- Complaint file establishment, 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, ACQUITY UPLC, ACQUITY UPLC I-Class, ACQUITY UPLC I-Class PLUS BSM, ACQUITY UPLC PLUS I-Class and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, High Pressure Liquid Chromatography | KIE | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Complaint file establishment | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Complaint file establishment | accessdata.fda.gov |
| Columns, Liquid Chromatography | DPM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Enzyme Immunoassay, Tracrolimus | MLM | 2 | Complaint file establishment | accessdata.fda.gov |
| Instrumentation, High Pressure Liquid Chromatography | LDM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mass Spectrometer, Clinical Use | DOP | 1 | Complaint file establishment | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | 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 Apparatus, High Pressure Liquid Chromatography
- All makers of Mass Spectrometer, Clinical Use
- All makers of Columns, Liquid Chromatography
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.