510(k) K970330 ยท CEM Electrode, Ion Specific, Potassium
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
| Applicant | Dade Intl., Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 14, 1997 |
| Received | Jan 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2015 | Siemens Healthcare Diagnostics, Inc. QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module.
Intended Use of the QuikLYTE module : The Na+, K+, Cl and Terminated |
CEM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.