510(k) K191973 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Lumpipulse G CA19-9-N
| Applicant | Fujirebio Dianostics, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 22, 2019 |
| Received | Jul 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191973
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.