510(k) K051543 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ELECSYS PRECICONTROL BONE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Jun 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051543
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.