The following data is part of a premarket notification filed by Epocal, Inc. with the FDA for Epoc Chloride Test And Epoc Creatinine Test.
| Device ID | K113726 |
| 510k Number | K113726 |
| Device Name: | EPOC CHLORIDE TEST AND EPOC CREATININE TEST |
| Classification | Electrode, Ion Based, Enzymatic, Creatinine |
| Applicant | EPOCAL, INC. 2060 WALKLEY RD. Ottawa, Ontario, CA K1g-3p5 |
| Contact | Roy Layer |
| Correspondent | Roy Layer EPOCAL, INC. 2060 WALKLEY RD. Ottawa, Ontario, CA K1g-3p5 |
| Product Code | CGL |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-19 |
| Decision Date | 2012-10-05 |
| Summary: | summary |