FDA Registration
Active
🇨🇦 Canada
epoc NXS Host - 0000 (11413497)
Reg #: 3004959793
·
FEI: 3004959793
·
Expires 2025
Products
11
Proprietary Names
9
Establishment Types
2
Classifications
11
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
- K200107
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 Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Device, Hematocrit Measuring | JPI | Class 2 | Hematology | No | 2020-06-11 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Electrode, Ion Based, Enzymatic, Creatinine | CGL | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2020-06-11 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Ph Rate Measurement, Carbon-Dioxide | JFL | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2020-06-11 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2020-06-11 |
Proprietary Names
epoc NXS Host - 0000 (11413497)
epoc NXS Host - 5553CA (11413506)
epoc NXS Host - 4D58MX (11413517)
epoc NXS Host - 544DRoW (11413518)
epoc NXS Host - 5553 (11413475)
epoc NXS Host - 4A50JP (11413498)
epoc® Blood Analysis System
epoc BGEM Test Cards (w/ CREA & CL) (10736382)
epoc BGEM Test Cards (w/ BUN & TCO2) (10736515)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device