FDA Registration
Active
🇺🇸 United States
WATERS CORPORATION
Reg #: 1218959
·
FEI: 1218959
·
Expires 2026
Products
9
Proprietary Names
35
Establishment Types
3
Classifications
9
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Registration Details
- Registration Name
- WATERS CORPORATION
- Registration Number
- 1218959
- FEI Number
- 1218959
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 34 MAPLE ST
- City
- MILFORD
- State
- MA
- ZIP
- 01757
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063868
Owner / Operator
- Firm Name
- WATERS CORPORATION
- Operator Number
- 1218959
- Address
- 34 Maple Street
- City
- Milford
- State
- MA
- Postal Code
- 01757
- Country
- US
- Correspondent
- Raajdeep Venkatesan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation, High Pressure Liquid Chromatography | LDM | Class 1 | Clinical Chemistry | No | 2009-11-10 |
| Mass Spectrometer, Clinical Use | DOP | Class 1 | Clinical Chemistry | No | 2004-04-22 |
| Columns, Liquid Chromatography | DPM | Class 1 | Clinical Chemistry | No | 1998-09-25 |
| Apparatus, High Pressure Liquid Chromatography | KIE | Class 1 | Clinical Chemistry | No | 2012-06-13 |
| Enzyme Immunoassay, Tracrolimus | MLM | Class 2 | Clinical Chemistry | No | 2007-07-03 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-07-03 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-07-03 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2021-10-19 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2021-10-19 |
Proprietary Names
ACQUITY UPLC I-Class
3777C Sample Manager
ACQUITY UPLC
ACQUITY UPLC Sample Organizer
ACQUITY UPLC PLUS I-Class
ACQUITY UPLC I-Class PLUS BSM
Xevo TQ-S Micro
Xevo TQ-XS
Xevo TQ
Xevo TQ-S
ACQUITY TQD
Xevo TQD
Xevo TQ Absolute
MASSTRAK C18
ACQUITY BEH
ACQUITY HSS T3
ACQUITY BEH Phenyl
MassTrak Online SPE Cartridges
Acquity UPLC Online SPE Manager
MassTrak Online SPE Analyzer System
MASS TRAK IMMUNOSUPPRESSANTS KIT
MASS TRAK KIT CALIBRATOR
MASS TRAK KIT QUALITY CONTROL
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
MassTrak Immunosuppressant Quality Control Set
MassTrak Steroid Serum QC Set 1
MassTrak Steroid Serum QC Set 3
MassTrak Steroid Serum QC Set 2
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device