510(k) K013373 ยท CEM Electrode, Ion Specific, Potassium
OMNI C ANALYZER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 2, 2001 |
| Received | Oct 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2003 | Roche Diagnostics Corp. PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734. Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.