510(k) K221813 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Nova Allegro UACR Assay, Nova Allegro Analyzer
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Nov 19, 2024 |
| Received | Jun 22, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K221813
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.