510(k) K983442 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ABBOTT ARCHITECT TSH
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Sep 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i TSH Reagent Kit, List Number 07P4830 Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.