510(k) K031879 ยท KHS Enzymatic, Carbon-Dioxide
COBAS INTEGRA CARBON DIOXIDE ASSAY
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 17, 2003 |
| Received | Jun 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031879
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.