K171247 is an FDA 510(k) clearance for the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test. This device is classified as a Electrode, Ion Specific, Urea Nitrogen (Class II - Special Controls, product code CDS).
Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on January 17, 2018, 264 days after receiving the submission on April 28, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K171247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2017 |
| Decision Date | January 17, 2018 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDS - Electrode, Ion Specific, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |