The following data is part of a premarket notification filed by Epocal, Inc. with the FDA for Blood Gas, Electrolyte And Metabolite Test Card.
| Device ID | K090109 |
| 510k Number | K090109 |
| Device Name: | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-15 |
| Decision Date | 2009-06-24 |
| Summary: | summary |