510(k) K953761 ยท LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
AXSYM TRICYCLIC ANTIDEPRESSANTS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 22, 1995 |
| Received | Aug 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2004 | Abbott Health Products, Inc. AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064 Terminated |
LDM | None listed |
| Mar 29, 2003 | Abbott Health Products, Inc. AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label:
AxSYM
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.