510(k) K111506 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ELECSYS PRECICONTROL VARIA 3
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 8, 2011 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2017 | Roche Diagnostics Corporation Elecsys PreciControl Varia 3 Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.