510(k) K200997 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Lumipulse G CA19-9-N
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 14, 2020 |
| Received | Apr 16, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200997
No recall in the FDA data names this 510(k).
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