FDA device listing
Atlas Cal Kit,Atlas Clarity Calibrator,Atlas Negative Control,Atlas Positive Control,Clinitek Atlas,Clinitek Atlas…
FDA device listing 1409510141 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Atlas Cal Kit,Atlas Clarity Calibrator,Atlas Negative Control,Atlas Positive Control,Clinitek Atlas,Clinitek Atlas 10,Clinitek Atlas 12,CLINITEK Atlas Carosel,CLINITEK Atlas Rack,Clinitek Family,Clinitek Novus Negative Control Strips,Clinitek Novus Positive Control Strips |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K932674 |
| Product codes | KQO |
| Device names | KQO - Automated Urinalysis System |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2900 |
| Review panels | Clinical Chemistry |
| Registered establishments | Siemens Healthcare Diagnostics Inc, Siemens Healthcare Diagnostics Inc., Siemens Healthcare Diagnostics, Inc. |
| Establishment registrations | 2432235, 3002637618, 3009448641 |
| FEI numbers | 2432235, 3002637618, 3009448641 |
| 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