FDA device listing
Acquity UPLC Online SPE Manager,MassTrak Online SPE Analyzer System,MassTrak Online SPE Cartridges
FDA device listing 1231851539 · WATERS CORPORATION
Key facts
| Proprietary names | Acquity UPLC Online SPE Manager,MassTrak Online SPE Analyzer System,MassTrak Online SPE Cartridges |
|---|---|
| Owner/operator | WATERS CORPORATION |
| Owner/operator number | 1218959 |
| Product codes | KIE |
| Device names | KIE - Apparatus, High Pressure Liquid Chromatography |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2260 |
| Review panels | Clinical Chemistry |
| Registered establishments | WATERS CORPORATION |
| Establishment registrations | 1218959 |
| FEI numbers | 1218959 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database