510(k) K052889 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
VITROS CA 19-9
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 20, 2005 |
| Received | Oct 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052889
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.