510(k) K183517 ยท JIF Enzymatic Method, Ammonia
Ammonia II
| Applicant | Roche Diagnostics Operations (Rdo), Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 8, 2019 |
| Received | Dec 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183517
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.