510(k) K192380 ยท NBC Test, Natriuretic Peptide
ST AIA-PACK BNP
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Aug 24, 2020 |
| Received | Aug 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192380
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.