K090109 is an FDA 510(k) clearance for the BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD. This device is classified as a Glucose Oxidase, Glucose (Class II - Special Controls, product code CGA).
Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 24, 2009, 160 days after receiving the submission on January 15, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K090109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2009 |
| Decision Date | June 24, 2009 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGA - Glucose Oxidase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |