FDA Registration
Active
🇺🇸 United States
DCA Systems
Reg #: 2432235
·
FEI: 2432235
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
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
- K071466
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 |
|---|---|---|---|---|---|
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2008-01-18 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2008-01-18 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2008-01-18 |
Proprietary Names
DCA Systems
DCA Vantage
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility