510(k) K100375 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 6, 2011 |
| Received | Feb 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100375
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.