FDA device listing
Access Free T4 Calibrators (P/N: 33885 MN MFG),Access Free T4 (P/N: C76421 MN and IE MFG)
FDA device listing 1691075737 · BECKMAN COULTER, INC.
Key facts
| Proprietary names | Access Free T4 Calibrators (P/N: 33885 MN MFG),Access Free T4 (P/N: C76421 MN and IE MFG) |
|---|---|
| Owner/operator | BECKMAN COULTER, INC. |
| Owner/operator number | 2050012 |
| Premarket submissions | K240273 |
| Product codes | CEC |
| Device names | CEC - Radioimmunoassay, Free Thyroxine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1695 |
| Review panels | Clinical Chemistry |
| Registered establishments | BECKMAN COULTER, INC., Beckman Coulter Ireland Inc |
| Establishment registrations | 2122870, 9680746 |
| FEI numbers | 2122870, 1000206808 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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