510(k) K093297 ยท KHP Acid, Lactic, Enzymatic Method
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
| Applicant | Epocal, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, Jun 9, 2010 |
| Received | Oct 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2013 | Epocal epoc BGEM Test Card (Catalogue number CT-1004-00-00).
quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.