510(k) K051890 ยท JZO System, Test, Thyroid Autoantibody
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 4, 2005 |
| Received | Jul 12, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2020 | Roche Diagnostics Operations, Inc. Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190 Terminated |
JZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.