The following data is part of a premarket notification filed by Epocal Inc. with the FDA for Epoc Blood Urea Nitrogen Test, Epoc Total Carbon Dioxide Test.
| Device ID | K171247 |
| 510k Number | K171247 |
| Device Name: | Epoc Blood Urea Nitrogen Test, Epoc Total Carbon Dioxide Test |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| Applicant | Epocal Inc. 2060 Walkley Road Ottawa, CA K1g 3p5 |
| Contact | Jennifer Armstrong |
| Correspondent | Jennifer Armstrong Epocal Inc. 2060 Walkley Road Ottawa, CA K1g 3p5 |
| Product Code | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-28 |
| Decision Date | 2018-01-17 |
| Summary: | summary |