510(k) K171059 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Nova StatSensor Creatinine Hospital Meter System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, May 26, 2017 |
| Received | Apr 10, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171059
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.