FDA device listing
Rapidlab 1200,Rapidlab 1200 Series,Rapidlab 800 Series,Rapidlab Blood Gas Systems
FDA device listing 2051331348 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Rapidlab 1200,Rapidlab 1200 Series,Rapidlab 800 Series,Rapidlab Blood Gas Systems |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K031560 |
| Product codes | CEM, CGA, CGZ, CHL, GKR, JFP, JGS, KHP |
| Device names | CEM - Electrode, Ion Specific, Potassium, CGA - Glucose Oxidase, Glucose, CGZ - Electrode, Ion-Specific, Chloride, CHL - Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, GKR - System, Hemoglobin, Automated, JFP - Electrode, Ion Specific, Calcium, JGS - Electrode, Ion Specific, Sodium, KHP - Acid, Lactic, Enzymatic Method |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1120, 862.1145, 862.1170, 862.1345, 862.1450, 862.1600, 862.1665, 864.5620 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | Siemens Healthcare Diagnostics Inc, Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Establishment registrations | 1219913, 2432235, 9610633, 3002637618 |
| FEI numbers | 1219913, 2432235, 3002637618, 3002806693 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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