510(k) K955435 ยท CDP Radioimmunoassay, Total Triiodothyronine
ACCESS TOTAL T3 ASSAY (MODIFICATION)
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 24, 1996 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955435
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2012 | Beckman Coulter Inc. Access Total T3 Reagent, PN: 33830
The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function Terminated |
CDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.