510(k) K961458 ยท JFP Electrode, Ion Specific, Calcium
AVL 9180 ELECTROLYTE ANALYZER
| Applicant | Avl Scientific Corp., Roswell GA, US |
| Decision | Substantially Equivalent, Jun 12, 1996 |
| Received | Apr 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2021 | Roche Diagnostics Operations, Inc. 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate sol Terminated |
JFP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.