510(k) K090109 ยท CGA Glucose Oxidase, Glucose
BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
| Applicant | Epocal, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, Jun 24, 2009 |
| Received | Jan 15, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090109
| 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 |
| Jul 19, 2012 | Epocal Inc epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System
Product Usage: Usage:
epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is Terminated |
CGA | None listed |
| Feb 16, 2011 | Synthes USA (HQ), Inc. 02.122.585, 85mm Spiral Blade, 14mm,
Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
For fixation of fractures and osteotomies of the proximal and distal femur in ado Terminated |
KTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.