510(k) K162606 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 23, 2017 |
| Received | Sep 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2019 | Roche Diagnostics Operations, Inc. AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids)
Catalog Number: 5694 Terminated |
JLW | None listed |
| Mar 15, 2019 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer Terminated |
JJE | None listed |
| Apr 3, 2018 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer, cobas 8000 Modular Series
The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is par Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.