Epocal Inc
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1971-2013 | Class II | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO | March 13, 2013 |
| Z-2034-2012 | Class II | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usag | June 28, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K200107 | epoc Blood Analysis System | June 5, 2020 |
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | January 17, 2018 |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | October 5, 2012 |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | June 9, 2010 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | March 30, 2010 |
| K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | June 24, 2009 |
| K061597 | EPOC BLOOD ANALYSIS SYSTEM | September 27, 2006 |