510(k) K050231 ยท JIT Calibrator, Secondary
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 6, 2005 |
| Received | Jan 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2020 | Roche Diagnostics Operations, Inc. Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer Terminated |
NIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.