510(k) K983439 ยท CDP Radioimmunoassay, Total Triiodothyronine
ABBOTT ARCHITECT FREE T3
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Sep 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2014 | Abbott Ireland Diagnostics Division ARCHITECT Total T3 Reagent Kit (7K64) consists of:
- 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% so Terminated |
CDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.