510(k) K163569 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Elecsys CMV IgM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 17, 2017 |
| Received | Dec 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.