510(k) K063684 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
COBAS LITHIUM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 21, 2008 |
| Received | Dec 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063684
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.