510(k) K854419 ยท JFT Fluorometric, Cortisol
TDX CORTISOL
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 25, 1985 |
| Received | Nov 4, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
JFT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.