510(k) K221326 ยท LCP Assay, Glycosylated Hemoglobin
Nova Allegro HbA1c Assay, Nova Allegro Analyzer
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Nov 22, 2024 |
| Received | May 6, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K221326
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.