FDA device listing
BCS XP System,BC Validation Kit
FDA device listing 1177540388 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | BCS XP System,BC Validation Kit |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K970431 |
| Product codes | GKP, JPA |
| Device names | GKP - Instrument, Coagulation, Automated, JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5400, 864.5425 |
| Review panels | Hematology |
| Registered establishments | Siemens Healthcare Diagnostics Inc., Siemens Healthcare Diagnostics Products GmbH |
| Establishment registrations | 2432235, 9610806 |
| FEI numbers | 2432235, 3001644026 |
| 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