510(k) K160495 · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
VITROS® Automation Solutions
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Feb 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2020 | Ortho Clinical Diagnostics VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 Terminated |
KLI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.