K113726 is an FDA 510(k) clearance for the EPOC CHLORIDE TEST AND EPOC CREATININE TEST. This device is classified as a Electrode, Ion Based, Enzymatic, Creatinine (Class II - Special Controls, product code CGL).
Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on October 5, 2012, 291 days after receiving the submission on December 19, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K113726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2011 |
| Decision Date | October 05, 2012 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGL - Electrode, Ion Based, Enzymatic, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |