510(k) K093555 ยท KQO Automated Urinalysis System
COBAS U411 TEST SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 2, 2010 |
| Received | Nov 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093555
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.