510(k) K203549 ยท CGA Glucose Oxidase, Glucose
Nova Primary Glucose Analyzer System
| Applicant | Nova Biomedical Corporation, Waltham ME, US |
| Decision | Substantially Equivalent, Oct 18, 2022 |
| Received | Dec 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203549
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.