510(k) K926475 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
ACCESS(R) THYROXINE ASSAY
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 15, 1993 |
| Received | Dec 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Beckman Coulter Inc. Access Total T4 Reagent Kit, Part Number: 33800,
Lot Numbers (s): All reagent pack lots
The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determ Terminated |
KLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.