510(k) K062379 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
COBAS INTEGRA CERULOPLASMIN
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 31, 2007 |
| Received | Aug 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062379
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.