FDA Registration
Active
🇺🇸 United States
Rapidlab 1200
Reg #: 1219913
·
FEI: 1219913
·
Expires 2025
Products
8
Proprietary Names
4
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 1219913
- FEI Number
- 1219913
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 333 Coney Street
- City
- E Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
Regulatory Submissions
- 510(k) Number
- K031560
Owner / Operator
- Firm Name
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Operator Number
- 9096044
- Address
- Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
- City
- Tarrytown
- State
- NY
- Postal Code
- 10591
- Country
- US
- Correspondent
- Mary Seeger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2008-01-18 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2008-01-18 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2008-01-18 |
Proprietary Names
Rapidlab 1200
Rapidlab 1200 Series
Rapidlab Blood Gas Systems
Rapidlab 800 Series
Establishment Types
Manufacture Medical Device