510(k) K801116 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
COBAS REAGENT FOR BUN
| Applicant | Roche Analytical Instruments, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 17, 1980 |
| Received | May 12, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801116
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.