FDA Registration
Active
🇺🇸 United States
RAPIDPoint® 500e Blood Gas System
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
9
Proprietary Names
2
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Siemens Healthcare Diagnostics Inc.
- Registration Number
- 2432235
- FEI Number
- 2432235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 511 Benedict Ave
- City
- Tarrytown
- State
- NY
- ZIP
- 10591
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192240
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 | 2020-03-30 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2020-03-30 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2020-03-30 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2020-03-30 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2020-03-30 |
Proprietary Names
RAPIDPoint® 500e Blood Gas System
iCa++ Quick Sampler
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility