Epocal, Inc.
Medical device manufacturer in Ottawa, CA.
7510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K200107 | epoc Blood Analysis SystemCHL · Special | 06/05/2020SE |
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional | 01/17/2018SE |
| K113726 | Epoc Chloride Test and Epoc Creatinine TestCGL · Traditional | 10/05/2012SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | 06/09/2010SE |
| K092849 | Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerCEM · Traditional | 03/30/2010SE |
| K090109 | Blood Gas, Electrolyte and Metabolite Test CardCGA · Traditional | 06/24/2009SE |
| K061597 | Epoc Blood Analysis SystemJGS · Traditional | 09/27/2006SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1971-2013 Class II | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples…This recall is being initiated because the affected lots of this product may yield results that are not… | 03/13/2013Terminated |
| Z-2034-2012 Class II | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System…Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality… | 06/28/2011Terminated |
| Z-0952-2009 | EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical…elevated range of potassium levels | 10/16/2008Terminated |