FDA device listing
Atellica CH Albumin BCP (AlbP),Atellica CI Analyzer; (Model 1900),Atellica CI Dilution Cuvette Segments,Atellica CI…
FDA device listing 1154356452 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Atellica CH Albumin BCP (AlbP),Atellica CI Analyzer; (Model 1900),Atellica CI Dilution Cuvette Segments,Atellica CI Reaction Cuvette Segments,Atellica Direct Connect for CI,Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL),Atellica Rack Handler |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K222116 |
| Product codes | CJW, JJE, JLW |
| Device names | CJW - Bromcresol Purple Dye-Binding, Albumin, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, JLW - Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1035, 862.1690, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS INC., Siemens Healthcare Diagnostics Manufacturing Ltd. |
| Establishment registrations | 1219913, 2432235, 2517506, 8020888 |
| FEI numbers | 1219913, 2432235, 2517506, 3007019572 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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