510(k) K180340 ยท CGA Glucose Oxidase, Glucose
Stat Profile Prime Plus Analyzer System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Sep 26, 2018 |
| Received | Feb 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180340
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.