K092849 is an FDA 510(k) clearance for the BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).
Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on March 30, 2010, 195 days after receiving the submission on September 16, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.
| 510(k) Number | K092849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2009 |
| Decision Date | March 30, 2010 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CEM - Electrode, Ion Specific, Potassium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1600 |