510(k) K853113 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
TD TRICYCLIC ANTIDEPRESSANTS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Aug 12, 1985 |
| Received | Jul 24, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2004 | Abbott Health Products, Inc. TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064. Terminated |
LFG | None listed |
| Mar 29, 2003 | Abbott Health Products, Inc. TDx/TDxFLx
TDx/TDxFLX Tricyclic Antidepressant Reagent
Distributed under the following label:
TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
91 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.