510(k) K061597 ยท JGS Electrode, Ion Specific, Sodium
EPOC BLOOD ANALYSIS SYSTEM
| Applicant | Epocal, Inc., Ottawa, CA |
| Decision | Substantially Equivalent, Sep 27, 2006 |
| Received | Jun 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061597
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2023 | Siemens Healthcare Diagnostics Inc epoc Host 2 as follows:
Product SMN
epoc Host 10736387
epoc Host 2, Canada 10736388
epoc Host 2, China 10736389
epoc Host 2, Japan 10736390
epoc Host 2, Refurbished 10736393
epoc H Open, Classified |
CHL | None listed |
| Feb 6, 2009 | Epocal EPOC BGE Test Card
The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the labo Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.