510(k) K973966 ยท CDP Radioimmunoassay, Total Triiodothyronine
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 31, 1997 |
| Received | Oct 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973966
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Beckman Coulter Inc. Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including:
Access 2, UniCel DxI 6 Terminated |
CDP | None listed |
| May 9, 2017 | Beckman Coulter Inc. Access Total T3, A34435H, Catalog No. 33830 Terminated |
CDP | None listed |
| 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.