FDA device listing
DxC 500 AU Clinical Chemistry Analyzer
FDA device listing 1608405102 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | DxC 500 AU Clinical Chemistry Analyzer |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K220977 |
| Product codes | JJE |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD., Beckman Coulter Mishima K.K. |
| Establishment registrations | 9612296, 3027977508 |
| FEI numbers | 3002807663, 3027977508 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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