FDA Registration
Active
🇨🇦 Canada
epoc Care-Fill Capillary Tubes (10736380/AT-0006-00-00)
Reg #: 3004959793
·
FEI: 3004959793
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- EPOCAL, INC.
- Registration Number
- 3004959793
- FEI Number
- 3004959793
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2060 Walkley Road
- City
- Ottawa Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K092849
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
US Agent
- Business Name
- Siemens Healthcare Diagnostics Inc.
- Contact Name
- Felix Akinrinola
- Address
- Point Of Care Headquarters, 333 Coney Street
- City
- East Walpole
- State
- MA
- ZIP
- 02032
- Country
- US
- [email protected]
- Phone
- 781 8561738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2017-11-14 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2017-11-14 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2017-11-14 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2017-11-14 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2017-11-14 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2017-11-14 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2017-11-14 |
Proprietary Names
epoc Care-Fill Capillary Tubes (10736380/AT-0006-00-00)
Establishment Types
Manufacture Medical Device